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  • A Phase 2 Open-Label Study of Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Older Patients or Patients with Significant Comorbidities Ineligible for Standard Chemotherapy. - NCT01716806

    Primary: To assess the objective response rates (ORR) of single-agent brentuximab vedotin and brentuximab vedotin in combination with other agents as frontline therapy in patients age > 60 years and in patients ineligible for conventional combination chemotherapy due to comorbidities. Secondary: (1). To evaluate safety and tolerability of single-agent brentuximab vedotin and the safety of brentuximab vedotin when given in combination with other agents (2). To assess duration of response (3). To assess complete remission (CR) rate (4). To assess progression-free survival (PFS) (5). To assess resolution of B symptoms (6). To assess pharmacokinetics and immunogenicity of brentuximab vedotin (all parts) and nivolumab (Part D only) (7). To assess overall survival (OS) (Parts E and F only)

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    • Protocol Number:
      011916

    • Principal Investigator:
      Andrew Evens M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Brentuximab vedotin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Andrew Evens M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Parts A, B, C, and D: 60 years of age or older
    • Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
    • Treatment-naive patients with CD30-expressing PTCL (Part F)
    • Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
    • Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
    • A CIRS score of 10 or greater
    • Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
    • Measurable disease of at least 1.5 cm as documented by radiographic technique
    • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

    Exclusion Criteria:

    • Symptomatic neurologic disease compromising IADLs or requiring medication
    • History of progressive multifocal leukoencephalopathy
    • Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
    • Concurrent use of other investigational agents
    • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
    • History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
    • Part D only:
    • Received any prior immune-oncology therapy
    • History of known or suspected autoimmune disease
    • Prior allogeneic stem cell transplant
    • History of cerebral vascular event within 6 months of first dose of study drug
    • Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
    • Known history of pancreatitis
    • Parts D, E, and F only:
    • Known cerebral/meningeal disease related to the underlying malignancy
    • Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients - NCT04871516

    The current standard of care for patients with invasive non-metastatic breast cancer who are candidates for Breast Conserving Surgery (BCS) is adjuvant whole breast radiation followed by an additional boost to the tumor bed. The benefit of tumor bed boost in reducing the local recurrence rates is established from historic clinical trials. However, the sequential delivery of the boost after surgery and radiation is done out of convention rather than any particular scientific rationale. Delivering the boost in the pre-operative setting provides the benefit of accurately directing the high radiation dose at the tumor and thus sparing normal breast tissue. It also takes advantage of a non-hypoxic microenvironment leading to an increase in the therapeutic ratio and superior outcome. We hypothesize that delivering the radiation boost pre-operatively will not result in a significantly higher risk of surgical wound complications. We also think that this approach will result in better cosmesis and less radiation toxicity to normal tissue. This is a prospective phase II single arm clinical trial evaluating the feasibility of delivering the breast radiation boost pre-operatively in non-metastatic, node negative breast cancer patients who are eligible for breast conserving surgery. Our primary objective is to measure the incidence of grade 3 or more wound complications at 1 month after surgery in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery and who get treated on protocol with a pre-operative boost. Secondary and tertiary objectives are: - to measure the rate of poor/fair cosmetic outcome as assessed by physicians at 1 year and 3 years after completion of radiation. - to measure patient reported cosmetic outcomes - to measure the incidence of acute and late radiation toxicity - to assess tumor pathophysiology before and after treatment - to measure the difference in the irradiated volume if a post-operative boost plan were to be done.

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    • Protocol Number:
      042005

    • Principal Investigator:
      Bruce Haffty MD

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Radiotherapy

      • Contacts:

      • Rutgers University Prinicipal Investigator: Bruce Haffty MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Breast cancer patients with biopsy proven invasive cancer
    • Clinically and radiographically node negative
    • No indication of metastatic disease
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Synchronous bilateral invasive cancer allowed
    • Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
    • Willingness to participate in the clinical trial and adhere to the study protocol
    • Individuals of all races, genders and ethnic groups are eligible for this trial

    Exclusion Criteria:

    • Need for neoadjuvant chemotherapy
    • Inflammatory breast cancer (cT4)
    • Multicentric tumor
    • Prior ipsilateral breast or thoracic RT
    • Contraindication for baseline magnetic resonance imaging (MRI)
    • Contraindication for surgery
    • Distant metastatic disease
    • Other synchronous cancer (besides bilateral breast)
    • Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
    • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer - NCT04253483

    AIM 1: To assess differences in HRQoL in the acute and long-term setting using the Expanded Prostate Index Composite (EPIC)-26 short form. Patient-reported HRQoL scores in the bowel, sexual and urinary domains will be evaluated at baseline, 1,3,6,9,12,18,24 and 36 months. A 10-point difference between the two treatment modalities will be considered significant. AIM 2: To assess tumor control and determine if the 36-month repeat prostate biopsy is a predictor of biochemical failure. A repeat prostate biopsy at 36 months and serial Prostate-Specific Antigen (PSA) measurements will be performed to assess local tumor control and biochemical failure, respectively. We will evaluate the predictive value of posttreatment prostate biopsy at 36 months with respect to biochemical failure.

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    • Protocol Number:
      081805

    • Principal Investigator:
      Lara Hathout MD

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Radiotherapy

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lara Hathout MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months)
    • Low-risk and intermediate-risk patients are eligible according to the following guidelines:
    • Low and intermediate-risk disease defined as:
    • Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) < 15 ng/ml
    • Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan are optional and are left at the discretion of the treating physician
    • Prostate MRI is recommended by not mandatory
    • No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization
    • Eastern Cooperative Oncology Group status 0-1
    • Judged to be medically fit for brachytherapy by a radiation oncologist
    • Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not permitted
    • Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
    • International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
    • Patients must sign a study specific informed consent form prior to study entry
    • Patients must by accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center. Investigators must assure themselves that patients enrolled in this trial will be available for complete documentation of the treatment, adverse events, and follow up
    • Protocol treatment is to begin within 4 weeks of patient randomization

    Exclusion Criteria:

    • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for >= 5 years
    • Prior or current bleeding diathesis
    • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior transurethral resection of the prostate (TURP), prior cryosurgery of the prostate
    • Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or bone scan
    • Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer
    • Severe, active co-morbidity, defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial for fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immumo-compromised patients
    • Patients with history of inflammatory colitis (including Crohn's disease and ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis and lupus are not eligible
    • Subjects who have a history of significant psychiatric illness
    • Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of Adjuvant Treatment with Cisplatin-Based Chemotherapy plus Concomitant Atezolizumab in Patients with Stage I (tumors equal to or greater than 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] Resected Non-Small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396. - NCT04367311

    Primary Objective: To estimate the percentage of patients with undetectable circulating tumor DNA (ctDNA) after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors equal to or greater than 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have detectable ctDNA after surgery, but prior to adjuvant therapy. Secondary Objectives: To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab in patients with stage I (tumors equal to or greater than 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA after 8 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 4 additional cycles of Atezolizumab) in patients with stage I (tumors & 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA after 12 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 8 additional cycles of Atezolizumab) in patients with stage I (tumors 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA during or after adjuvant chemotherapy + Atezolizumab followed by Atezolizumab for up to 13 additional cycles who had no detectable ctDNA after surgery To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection, regardless of ctDNA status after surgery To estimate the 1 year DFS in all patients treated on study To estimate the 1 year DFS in patients with no detectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab who had detectable ctDNA after surgery. To estimate the 1 year DFS in patients with detectable ctDNA after 1 year of adjuvant therapy on study

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    • Protocol Number:
      032007

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) CISPLATIN PEMETREXED DOCETAXEL

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Age >= 18 years at the time of consent.
    • ECOG Performance Status of 0-1 within 28 days prior to registration.
    • Patients must have undergone complete surgical resection of their stage I (tumors >= 4cm), IIA, IIB, and select IIIA [T3N1-2, T4N0-2] NSCLC according to the AJCC 8th edition with negative margins (R0).
    • Squamous or non-squamous NSCLC histology. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
    • Surgery for this lung cancer must be completed <= 60 days prior to starting treatment.
    • Must have tissue available to perform prospective correlative testing. Tissue block is preferred but 10-15 unstained slides (5 μm thick) are also acceptable. If prior PD-L1 results with Dako 22C3 antibody are not available, an additional 5 unstained slides (4 μm thick) must be submitted.
    • Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
    • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
    • Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab.
    • A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (> or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
    • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Contraception method must begin starting from the time of informed consent until 5 months after treatment discontinuation.
    • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
    • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 5 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

    Exclusion Criteria:

    • Tumors that have any component of small cell or large cell neuroendocrine histology are NOT eligible.
    • Tumors that are known to harbor EGFR mutations or ALK re-arrangements are NOT eligible.
    • Prior chemotherapy, radiation therapy, or immunotherapy is NOT allowed for the treatment of this lung cancer.
    • Prior chemotherapy and/or radiation therapy is permissible for the treatment of other previous cancers, but must have been completed at least 3 months prior to registration for this trial.
    • Other active cancers.
    • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
    • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 1 week prior to registration.
    • Has severe hypersensitivity (>= Grade 3) to atezolizumab and/or any of its excipients.
    • Has active or history of autoimmune disease or immune deficiency that includes but is not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
    • Known interstitial lung disease that is symptomatic or may interfere with detection or management of suspected drug-related pulmonary toxicity are not permitted.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Has a severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    • Has a known history of Human Immunodeficiency Virus (HIV). Note: HIV testing is not required.
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: If Hepatitis B and Hepatitis C status is unknown, testing is required:
    • Subject must have negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
    • Subject must have negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. A positive HCV RNA test is sufficient to diagnose active HCV infection in the absence of an HCV antibody test.
    • Has a known history of active TB (Bacillus Tuberculosis).
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of study drug.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-Small Cell Lung Cancer (NSCLC) with Primary Tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153. - NCT04317534

    Primary Objective: To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non- small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS score. Secondary Objectives: - To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves overall survival compared with observation in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS. - To evaluate the disease-free survival and overall survival rate sat 1year, 2 years, and 3 years on each arm. - To characterize thet oxicity profile of adjuvant Pembrolizumab following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size.

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    • Protocol Number:
      032006

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy single agent systemic Surgery

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection.
    • Males and females age ≥ 18 years at the time of consent.
    • ECOG Performance Status of 0-1 within 28 days prior to registration.
    • Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0).
    • NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
    • NOTE: Staging will be according to the AJCC 8th edition.
    • Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension.
    • Surgery for this lung cancer must be completed at least 28 days prior to registration.
    • Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. If prior PD-L1 results with Dako 22C3 antibody are not available from a CLIA-accredited laboratory, subjects must be able to provide 5µm x 4unstained slides for prospective analysis to be used for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H&E slides from current diagnosis for future NGS and/or other genetic analyses.
    • Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
    • Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For subjects randomized to the pembrolizumab arm: If there is > 72 hours between the screening test and C1D1, another pregnancy test (urine or serum) must be performed and must be negative before the subject may start C1D1.
    • NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.1.4 for definitions.
    • NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP) OR
    • A WOCBP who is using a highly effective contraceptive method (failure rate of <1% per year), or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study drug. See contraceptive guidance in Section 5.1.4 of the protocol.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

    Exclusion Criteria:

    • Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV.
    • Patients with tumors that are known to harbor actionable EGFR mutations.
    • Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
    • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
    • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
    • Has had an allogenic tissue/solid organ transplant.
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Has an active infection requiring systemic therapy.
    • Has a known history of Human Immunodeficiency Virus (HIV). Note: HIV testing is not required unless mandated by local health authority.
    • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: Hepatitis B and Hepatitis C testing is not required unless mandated by local health authority.
    • Has active TB (Bacillus Tuberculosis) infection.
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery. - NCT05296681

    PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

    View All Details
    • Protocol Number:
      072201

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy (NOS)

    • Drugs Involved:
      NBT-NM108 IRINOTECAN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Biopsy proven and metastatic colon cancer
    • Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency.
    • Performance Status (PS) 0-1
    • Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) >1500/uL; Creatinine < 1.5 x Upper Limit of Normal (ULN); Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL
    • No known UGTA1A* genotype

    Exclusion Criteria

    • Grade two diarrhea or greater (4-6 movements per day over baseline)
    • Inability to take oral supplements
    • Current antibiotic therapy
    • Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection.
    • History of the following infections and/or disease which could lead to diarrhea:
    • History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool.
    • History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib. - NCT04457596

    Primary Objective: To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary Objectives: 1. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: - overall survival (OS) - breast cancer free survival (BCFS) - distant recurrence-free survival (DRFS) - disease-free survival (DFS) - brain metastases-free survival (BMFS). 2. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

    View All Details
    • Protocol Number:
      042106

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Tucatinib/Placebo ado-trastuzumab/T-DM1

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required * Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
    • Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
    • Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients
    • Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
    • The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis * Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
    • Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
    • Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
    • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
    • Prior treatment must have consisted of >= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of >= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration [FDA]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received >= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
    • Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a [trastuzumab deruxtecan]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
    • Patients may have received =< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =< 5 weeks prior to registration * Note: Both of the following two criteria need to be met for the patient to be eligible for this study
    • An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
    • Patients must be registered on study within =< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
    • All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response [pCR]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of >= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants
    • Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =< grade 1
    • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
    • Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision
    • For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
    • Lymph node surgery ** The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Absolute neutrophil count (ANC) >= 1,000/mm^3
    • Hemoglobin >= 8 g/dL (Note: packed red blood cells [PRBC] transfusion is not permitted to achieve eligibility)
    • Platelet count >= 100,000/mm^3
    • Creatinine =< 1.5 x upper limit of normal (ULN)
    • Total bilirubin =< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Screening left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility

    Exclusion Criteria:

    • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
    • Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
    • Stage IV (metastatic) breast cancer
    • History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
    • Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
    • Evidence of recurrent disease following preoperative therapy and surgery
    • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
    • History of exposure to the following cumulative doses of anthracyclines: doxorubicin > 240 mg/m^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m^2. For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
    • Cardiopulmonary dysfunction as defined by any of the following:
    • History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II
    • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
    • High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 [Mobitz 2] or third degree AV-block)
    • Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
    • History of a decrease in left ventricular ejection fraction (LVEF) to < 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
    • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
    • Current severe, uncontrolled systemic disease
    • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment
    • History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
    • Peripheral neuropathy of any etiology that exceeds grade 1
    • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
    • Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
    • Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair. - NCT02912559

    Primary Objective: To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve DFS compared to FOLFOX alone in patients with stage III colon cancers and dMMR. Secondary Objectives: 1. To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR. 2. To assess the adverse events (AE) profile and safety of each treatment arm, using the CTCAE and PRO-CTCAE Quality of Life Objective: The quality of life objective will be to determine the impact of the addition of atezolizumab to FOLFOX on patient-reported neuropathy, health-related QOL, and functional domains of health-related QOL. The quality of life analysis will also access the efficacy of atezolizumab adjusting for baseline QOL and fatigue measurements. Potential Correlative Science Objectives: 1..Testing of banked specimens will not occur until an amendment to this treatment protocol (or separate correlative science protocol) is reviewed and approved in accordance with National Clinical Trials Network (NCTN) policies. 2. To determine if the Immunoscore can predict the efficacy of atezolizumab for disease free survival among patients with stage III colon cancer. 3. To assess whether circulating immune cell populations can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer. 4. To explore the associations of genomic alterations identified in cfDNA with DFS in patients treated with FOLFOX with or without atezolizumab. 5. To assess whether soluble markers of systemic inflammation in blood can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer. 6. To assess the relationship between baseline plasma 25(OH) D levels, change in 25(OH)D levels, and DFS and OS in patients with stage III colon cancer receiving FOLFOX +/- atezolizumab. 7..To determine the ability of using fecal microbiota and their metabolic products to predict survival benefit from anti-PD-L1 antibody therapy in dMMR colon cancer patients. 8. To determine if hypermutation or hyper-indel status is associated with response to atezolizumab. 9. To determine if unique mRNA expression signatures are predictive of disease-free survival among patients receiving adjuvant chemotherapy for stage III colon cancer. 10. To determine if the efficacy of atezolizumab differs among dMMR cancers due to germline MMR mutation (MLH1, MSH2, MSH6, PMS2) versus those with MLH1 hypermethylation and CIMP in patients with stage III colon cancer. 11. To identify overall mutational burden and number of putative tumor neoantigens in colon carcinoma specimens.

    View All Details
    • Protocol Number:
      071808

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) mFOLFOX6

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve)
    • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
    • Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
    • Patients who are known to have Lynch syndrome, have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2), and have been shown to be dMMR by IHC are eligible to participate
    • Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margins are acceptable so long as en bloc resection was performed; proximal or distal margin positivity is not permitted
    • Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary; patients with more than one primary colon adenocarcinoma are eligible if the qualifying stage III tumor is confined to the colon, and not rectum, and the other cancers of lower stage are removed in the en bloc R0 resection
    • Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (included with distal), and further categorization will be as follows: cecum/ascending, transverse, descending, sigmoid colon, or rectosigmoid colon
    • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
    • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6
    • Performance Status:
    • Patients < 16 years of age: Lansky >= 50%
    • Patients 16 to < 18 years of age: Karnofsky >= 50%
    • Patients >= 18 years of age: Eastern Cooperative Oncology Group (ECOG) performance status =< 2
    • This study involves: 1) an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; and 2) an agent that has known genotoxic, mutagenic, and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)
    • Absolute neutrophil count (ANC) >= 1500 mm^3
    • Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
    • Creatinine =< 1.5 x upper limit of normal (ULN) or
    • Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
    • Alternatively, for patients < 18 years of age, maximum serum creatinine =< the below age-gender-specific norms:
    • 12 years: 1.2 (male and female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • 16 to < 18 years: 1.7 (male), 1.4 (female)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
    • No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
    • No known active hepatitis B or C
    • Active hepatitis B can be defined as:
    • Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
    • Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
    • Persistent or intermittent elevation in ALT/AST levels
    • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Active hepatitis C can be defined as:
    • Hepatitis C antibody (AB) positive AND
    • Presence of hepatitis C virus (HCV) RNA
    • Excluded if known active pulmonary disease with hypoxia defined as:
    • Oxygen saturation < 85% on room air, or
    • Oxygen saturation < 88% despite supplemental oxygen
    • No grade >= 2 peripheral motor or sensory neuropathy
    • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
    • No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
    • No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
    • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
    • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
    • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]. - NCT03793166

    Primary Objective: To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab. Secondary Objective(s): a. To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib; b. To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months); c. To evaluate the rates of discontinuing therapy at 1 year; d. To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab; e. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinibnivolumab.

    View All Details
    • Protocol Number:
      081910

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      Cabozantinib (COMETRIQ) IPILIMUMAB (MDX-010) Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • STEP I REGISTRATION CRITERIA
    • Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.
    • Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
    • Measurable disease as defined in the protocol.
    • Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following: Karnofsky performance status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal [LLN], corrected calcium concentration greater than upper limit of normal [ULN], absolute neutrophil count greater than ULN, platelet count > ULN).
    • Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment.
    • Karnofsky performance status >= 70%.
    • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as > 1 year since completion of systemic therapy.
    • No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days] and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as above are allowed).
    • No cancer therapy less than 28 days prior to registration; this includes radiation therapy, except for bone lesions less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy.
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 14 days prior to registration is required.
    • Age >= 18 years
    • Absolute neutrophil count (ANC) >= 1,500/mm^3.
    • Platelet count >= 100,000/mm^3.
    • Hemoglobin >= 8 g/dL.
    • Calculated (Calc.) creatinine clearance >= 30 mL/min.
    • Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1.
    • Total bilirubin =< 1.5 x upper limit of normal (ULN).
    • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present.
    • STEP 2 REGISTRATION ELIGIBILITY CRITERIA
    • Successful completion of at least 1 cycle of ipilimumabivolumab.
    • Resolution of any treatment-related adverse events to grade 1 or less per dose modification section (this criteria does not include any adverse events [AEs] not attributable to treatment which are present due to disease). Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed.
    • No more than 70 days from last dose of ipilimumabivolumab.

    Exclusion Criteria:

    • Active autoimmune disease requiring ongoing therapy.
    • Ongoing acute toxicity > grade 2 from previous treatment.
    • History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies.
    • History of human immunodeficiency virus (HIV) or active hepatitis B/C, or active tuberculosis (purified protein derivative [PPD] response without active TB is allowed).
    • Concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
    • Uncontrolled adrenal insufficiency.
    • Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90 mmHg).
    • Major surgery less than 28 days prior to registration.
    • Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration.
    • Any arterial thrombotic events within 180 days prior to registration.
    • Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration.
    • Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations.
    • Lesions encasing or invading any major blood vessels (this does not include tumor thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with tumor thrombus extending into/through renal vein are considered eligible.
    • Moderate of severe hepatic impairment (Child-Pugh B or C).
    • Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed).
    • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms.
    • Unstable cardiac arrhythmia within 6 months prior to registration.
    • Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =< 90 days prior to registration.
    • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration.
    • Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration.
    • Untreated hypothyroidism, evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome.
    • Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
    • Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart Association class 3-4 heart failure symptoms

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute of New Jersey
  • Alliance A021703: Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS). - NCT04094688

    Primary Objective: To compare the progression-free survival (PFS) of patients receiving high-dose vitamin D3 in combination with standard chemotherapy (FOLFOX or FOLFIRI) and bevacizumab versus those receiving standard-dose vitamin D3 in combination with standard chemotherapy and bevacizumab.

    View All Details
    • Protocol Number:
      072001

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      LEUCOVORIN IRINOTECAN FLUOROURACIL BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed advanced/metastatic colorectal adenocarcinoma for which metastasectomy is not planned.
    • No known mismatch repair deficiency (dMMR) or high-frequency microsatellite instability (MSI-H) disease.
    • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
    • No prior systemic treatment for metastatic disease.
    • Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation. The last course of adjuvant therapy must have been completed > 12 months prior to colorectal cancer recurrence.
    • Patients may have received prior standard rectal cancer chemoradiation. Previous radiation therapy must have been completed >= 4 weeks prior to registration.
    • No continuous daily use of vitamin D supplements >= 2,000 IU per day for the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements >= 2,000 IU per day if total duration < 12 months in the 12 months prior to registration. Patients may have had continuous daily use of vitamin D supplements < 2,000 IU per day for any duration prior to registration.
    • Patients must have completed any major surgery or open biopsy >= 4 weeks prior to registration and must have completed any minor surgery or core biopsy >= 1 week prior to registration. (Note: insertion of a vascular access device is not considered major or minor surgery.) Patients must have recovered from the effects of any surgery (e.g. wound is healed, no active infection, no drains, etc.) prior to registration.
    • Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 14 days prior to registration is required.
    • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
    • Absolute neutrophil count >= 1,500/mm^3.
    • Platelet count >= 100,000/mm^3.
    • Hemoglobin >= 9 g/dL.
    • Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (Calc.) creatinine clearance (CrCl) > 30 mL/min.
    • Calcium =< 1.0 x ULN. * Corrected for albumin level if albumin not within institutional limits of normal.
    • Total bilirubin =< 1.5 x ULN. * If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =< 1.5 x ULN if patient to receive FOLFIRI; direct bilirubin =< 3.0 x ULN if patient to receive leucovorin, infusional fluorouracil, and oxaliplatin (modified [m]FOLFOX6).
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN. * AST/ALT < 5 x ULN if clearly attributable to liver metastases.
    • Urine protein to creatinine (UPC) ratio =< 1 mg/dL OR urine protein =< 1+. * If urine protein is above 1, then 24-hour urine must be ≤ 1 g/24 hours.
    • No resectable metastatic disease for which potentially curative metastasectomy is planned.
    • No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have been free of disease for >= 3 years.
    • No significant history of bleeding events or bleeding diathesis =< 6 months of registration unless the source of bleeding has been resected.
    • No history of arterial thrombotic events, including, but not limited to, transient ischemic attack, cerebrovascular accident, unstable angina, angina requiring surgical or medical intervention, or myocardial infarction =< 6 months of registration.
    • No history of clinically significant peripheral artery disease =< 6 months of registration.
    • No history of uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or greater.
    • No history of gastrointestinal (GI) perforation =< 12 months of registration except for GI perforation related to a primary colorectal tumor that has since been fully resected.
    • No history of malabsorption, uncontrolled vomiting or diarrhea, or any other disease significantly affecting GI function that could interfere with the absorption of oral agents.
    • No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study agents.
    • No uncontrolled hypertension (defined as blood pressure [BP] > 160/90).
    • No serious or non-healing wound, ulcer, or bone fracture.
    • No uncontrolled intercurrent illness, including, but not limited to, psychiatric illness/social situations that, in the opinion of the treating physician, may increase the risks associated with participation or treatment on the study or may interfere with the conduct of the study or interpretation of the study results.
    • Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
    • On effective anti-retroviral therapy
    • Undetectable HIV viral load by standard clinical assay =< 6 months of registration.
    • No known pre-existing hypercalcemia =< 6 months of registration.
    • No known active hyperparathyroid disease or other serious disturbance of calcium metabolism =< 5 years of registration.
    • No predisposing colonic or small bowel disorders in which symptoms are uncontrolled as indicated by > 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy are allowed per treating physician discretion.
    • No symptomatic genitourinary stones =< 12 months of registration.
    • Patients with treated brain metastases are eligible if follow-up imaging after central nervous system (CNS)-directed therapy shows no evidence of progression >= 28 days prior to registration.
    • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of protocol-specified therapy after registration.
    • No uncontrolled seizure disorders.
    • No grade >=2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 regardless of causality.
    • Patients must be able to swallow oral formulations of the agent.
    • Concurrent use of supplemental calcium and/or vitamin D is not permitted. Patients must discontinue the supplement(s) at least 7 days prior to registration.
    • Concurrent use of thiazide diuretics (e.g. hydrochlorothiazide) is not permitted. Patients must discontinue the drug(s) or switch to an alternative anti-hypertensive agent at least 7 days prior to registration.
    • Chronic concomitant treatment with oral corticosteroids, lithium, phenytoin, quinidine, isoniazid, and/or rifampin are not permitted. Patients must discontinue the agent(s) at least 7 days prior to registration. Short-term use of corticosteroids as antiemetic therapy is acceptable.
    • Concurrent use of other anti-cancer therapy including chemotherapy, targeted, and/or biological agents is not permitted.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • ALLIANCE A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer. - NCT04340141

    Primary Objective: 1. To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. Secondary Objectives: 1. To evaluate and compare disease-free survival (DFS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 2. To evaluate and compare time to locoregional recurrence (TLR) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 3. To evaluate and compare time to distant metastases (TDM) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 4. To evaluate and compare the R0 resection rate in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 5. To evaluate and compare rate of unresectability in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 6. To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm. 7. To evaluate and compare mFOLFIRINOX dose intensity delivered and number of cycles received in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX 8. To evaluate and compare adverse event profile in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 9. To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX. 10. To prospectively assess the influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the disease-free survival and overall survival among patients with localized pancreatic cancers. 11. To assess the influence of diet, obesity, physical activity, and other lifestyle habits on the risk of toxicity associated with chemotherapy. 12. To evaluate the ability of CT-based radiomics in distinguishing post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor in patients randomized to the perioperative therapy arm. 13. To determine whether CT-based radiomics retrieved from baseline examination may act as non-invasive predictors of survival outcome in patients randomized to the adjuvant therapy arm.

    View All Details
    • Protocol Number:
      072108

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      mFOLFIRINOX

      • Contacts:

      • RWJBarnabas Health - Saint Barnabas Medical Center, Livingston Prinicipal Investigator: Russell Langan MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      PRE-REGISTRATION:
    • Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma
    • TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
    • Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT:
    • No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
    • Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
    • No evidence of metastatic disease
    • Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging REGISTRATION:
    • Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
    • Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection
    • No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
    • Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Total Neuropathy Score < 2
    • Absolute neutrophil count (ANC) >= 1,500/uL
    • Platelet count >= 100,000/uL
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =< 3.0)
    • Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min (Calculated using the Cockcroft-Gault equation)
    • No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
    • No comorbid conditions that would prohibit curative-intent pancreatectomy
    • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration
    • Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute of New Jersey
  • ALLIANCE A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease. - NCT04114981

    Primary: - To ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis. Secondary: - To ascertain if there is better emotional well-being at 9 months as assessed by the FACT-BR in patients with resected brain metastasis undergoing FSRS compared to SSRS (Primary QOL Objective). - To ascertain whether there is improved overall survival in patients with resected brain metastases who undergo FSRS compared to patients who receive SSRS. - To ascertain in patients with resected brain metastases whether there is improved overall QOL as assessed by the FACT-BR and LASA in patients who receive FSRS compared to patients who receive SSRS (Secondary QOL Objective). - To compare the functional independence in patients who receive FSRS to patients who receive SSRS. - To tabulate and descriptively compare the post-treatment adverse events associated with the interventions, including the potential impact of immunotherapy and targeted therapy. - To compare rates of radiation necrosis at 12 months in patients who receive FSRS to patients who receive SSRS. - To evaluate if there is any difference in CNS failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease) in patients who receive FSRS compared to patients who receive SSRS after resection of brain metastasis. - To ascertain in patients with resected brain metastases whether there is increased time to WBRT in patients who receive FSRS compared to patients who receive SSRS. - To determine in long-term survivors (patients who are alive more than 12 months from time of randomization) whether there is better emotional well-being and overall QOL as assessed by the FACT-BR and LASA in patients who receive FSRS to the surgical bed compared to patients who receive SSRS (Secondary QOL Objective). - To ascertain if time to surgical bed failure as assessed by central review is increased with FSRS compared to SSRS in patients with resected brain metastasis. - To ascertain in patients with resected brain metastases whether there is improved QOL as assessed by all other total and individual FACT-BR and LASA items and subscale values in patients who receive FSRS compared to patients who receive SSRS (Exploratory QOL Objective). - To determine in patients with resected brain metastases whether there is less cognitive progression in patients who receive FSRS to the surgical bed compared to patients who receive SSRS (Exploratory Cognitive Objective).

    View All Details
    • Protocol Number:
      142001

    • Principal Investigator:
      Anupama Chundury

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Surgery Radiotherapy

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anupama Chundury

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      PRE-REGISTRATION:
    • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
    • Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening. o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
    • Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept. o Note: The metastases size restriction does not apply to the resected brain metastasis.
    • One brain metastasis must be completely (gross total resection) resected =< 30 days prior to pre-registration. o NOTE: May not have had resection of more than one brain metastasis.
    • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
    • Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =< 30 days prior to pre-registration.
    • Karnofsky performance status of >= 60.
    • For women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required.
    • Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
    • A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
    • Ability to complete an MRI of the head with contrast.
    • The brain metastasis must be located > 5 mm of the optic chiasm; the brain metastasis must be located outside the brainstem (i.e. not inside the brainstem).
    • Must not have any prior whole brain radiation therapy.
    • Past radiosurgery to other lesions is allowed. o NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol).
    • May not have primary germ cell tumor, small cell carcinoma, or lymphoma.
    • No evidence of leptomeningeal metastasis (LMD). o NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.
    • Must be fluent in English, Spanish, or French. REGISTRATION: • Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
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