A051701

Randomized Phase II/III Study of Venetoclax (ABT 199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double-Expressing Lymphomas.

Inclusion Criteria

•  Pathologic diagnosis of Diffuse Large B-cell lymphoma (DLBCL) or High grade B-cell lymphoma (HGBCL)
•  Double Hit Lymphoma (DHL) or Double Expressing Lymphoma (DEL)
  •  DHL is defined as high grade B-cell lymphoma with one of the below:
•  Translocations of MYC and BCL2
•  Translocations of MYC and BCL2 and BCL6 (triple hit lymphoma)
•  Translocations of MYC and BCL6 without BCL2 translocation BUT with IHC expression of BCL2 (≥50%)

Exclusion Criteria

•  No prior treatment for DLBCL/HGBCL is allowed with the exception of corticosteroids administered for palliation, or a single cycle of either R-CHOP or DA-EPOCH-R administered prior to enrollment.

• Cooperman Barnabas Medical Center

ALCHEMIST

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
1 Screening and 2 Treatment Protocols (for EGFR and ALK Mutations).

Key Inclusion:

• Pre-surgical suspected diagnosis of resectable NSCLC Clinical Stage IIIa, IIa or IIb, or large Ib (at least 4 cm).
• Post-surgical must have completely resected NSCLC with negative margins. Pathologic stage IIIa, IIa or IIb, or large Ib (at least 4 cm).
• No Neoadjuvant therapy
• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4.

Treatment:

• No mutation via central testing: Standard care
• EGFR Mutation: Erlotinib vs Observation
• ALK translocation/inversion: Crizotinib vs Observation

Principal Investigator: Michael Scoppetuolo, MD

• Cooperman Barnabas Medical Center

Alliance - A221505

Phase III Randomized Trial of Hypofractionated post mastectomy radiation with breast reconstruction.

Final AJCC stage IIa-IIIa – (path stage T0N1a-2a, T1N1a-2a, T3N0-2a, all M0 status) Pathologic stage for all pts not receiving neoadjuvant chemo. Higher of the clinical or path T and N stage, if receiving neoadjuvant chemo. Patients with path N0 at the time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to induction chemo.

No prior hx of ipsilateral breast ca (invasive disease or DCIS) LCIS and benign breast disease is allowed.

No hx of prior or concurrent contralateral invasive breast ca.

No significant post mastectomy complications requiring an unplanned re-operation or admission for IV antibiotics. Re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable.

Radiation oncologist is NOT planning to utilize a chest wall/scar boost.

Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after RT.

• Cooperman Barnabas Medical Center

Alliance 011401

Breast (HER2 Neg) - A randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer. – (defined by BMI > 27)

• Dx of breast ca within past 12 months
• Her 2 neg
• ER and PR Neg: T2-3N0 or T0-3 N1-3 (N1mi –not eligible)
• ER and/or PR positive: T0-3N1-3, or T3N0 (N1mi- not eligible)
• adjuvant or neoadjuvant chemo sx, and RT must be completed at least 21 days prior to registration

Principal Investigator:  Anna Litvak, MD

• Cooperman Barnabas Medical Center

Anemia Study – Fibrogen

A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

Inclusion Criteria:

•  Diagnosis of non-myeloid malignancy. Current documentation of disease burden (e.g. CT scan) within 3 months prior to enrollment (Day 1).
•  Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hgb ≤10.0 g/dL at screening
•  Planned concurrent treatment of cancer myelosuppressive chemotherapy) for at least 8 additional weeks

Exclusion Criteria:

•  Patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure
•  Patients who are only receiving hormonal products, biological products, novel immunosuppressive products (such as PD-1 and PD-L1 checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer. (Patients receiving concomitant myelosuppressive therapy if not intended for cure may be allowed to participate)
•  Patients who prefer a Red Blood Cell (RBC) transfusion as treatment of anemia at time of
• study entry, over receiving the investigational drug Roxadustat
•  Received an RBC transfusion or ESA within 4 weeks of enrollment (Day 1)

• Cooperman Barnabas Medical Center

Biomarker

An Exploratory Biomarker Study of Checkpoint Inhibitors (PD-1, PD-L1 and CTLA-4) used as Monotherapy or in Combination in Patients with Cancer

Inclusion

• • eligible to receive CPI (must be CPI naïve) with cancer for whom treatment with a checkpoint inhibitor(s) is given either as monotherapy or in combination with another CPI.

•  blood samples at baseline
•  on-treatment (after two doses of CPI, within 3 days prior to the third CPI infusion), 6 months post-first CPI dose, 12 months post-first CPI dose, at the time of event of special interest (EOSI) occurrence, and 4-6 weeks post-EOSI.

• Cooperman Barnabas Medical Center

Breast Cancer Weight Loss Study (BWEL Study)

Lead: Dr. Anna Litvak

Website: https://clinicaltrials.gov/ct2/show/NCT02750826?term=o%09Alliance+011401&rank=1

• Cooperman Barnabas Medical Center

COMPASS

EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

Key Inclusion:

• HER2-Positive primary invasive breast carcinoma
• ER/PR known – Positive and Negative both eligible
• Clinical Stage II and IIIa (T2-3/N0-2/M0) at diagnosis:
  • Without nodal involvement (cN0) are eligible if T size at least 2.0 cm.
  • With nodal involvement (cN1-2) are eligible if T as least 1.5 cm.
• Patient with two separate invasive breast cancers (ipsilateral or bilateral) are eligible if both cancers are HER2-positive (as defined in 3.1.3 ) and at least one meets protocol eligibility (i.e., ≥ 1.5 cm if cN1-2; ≥ 2 cm if cN0) (neither tumor can be T4 or N3).
• Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets eligibility criteria.

Treatment:

Neoadjuvant: Paciltaxel or Docetaxel with Trastuzumab. Those with pCR receive Trastuzumab and Pertuzumab. Those who do NOT achieve pCR receive standard of care.

Principal Investigator: Ann Ltivak, MD
 

• Cooperman Barnabas Medical Center

Covid Registry

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

•  Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
•  Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) for metastatic cancer. Eligible treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, or radiation therapy;

or

• Patients is receiving adjuvant treatment for non-metastatic (Stage I-III) cancer and has received intravenous chemotherapy, immunotherapy, targeted therapy, or radiation therapy within the past 6 weeks; or
•  Patient has received an allogenic stem cell transplant or CAR-T cell or other modified cellular therapy at any time; or
•  Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease;

• Cooperman Barnabas Medical Center

DESTINY-Breast

A phase 3 multi-center, randomized open label active controlled trial of DS 8201a, an ADC versus treatment of physicians' choice for HER2 low, unresectable or metastatic breast cancer

Key Inclusion Criteria:

• HER2 low expression (IHC2+/ISH- OR IHC 1+)
• refractory to endocrine therapy (progressed after 1 line of endocrine therapy)
• treated with at least 1 and no more than 2 lines of prior chemo for metastatic disease

Key Exclusion Criteria:

• no ILD
• active brain mets

Treatment:

2:1 to DS-8201a versus capecitabine, eribulin, gemcitabine, paclitaxel, nab-paclitaxel

Principal Investigator:  Anna Litvak, MD

• Cooperman Barnabas Medical Center

EMERALD

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast

https://clinicaltrials.gov/ct2/show/NCT03778931?term=EMERALD&recrs=a&rank=3

Principal Investigator: Dr. Anna Litvak, MD

• Cooperman Barnabas Medical Center

GU008

NRG-GU008, RANDOMIZED PHASE III TRIAL INCORPORATING ABIRATERONE ACETATE WITH PREDNISONE AND APALUTAMIDE AND ADVANCED IMAGING INTO SALVAGE TREATMENT FOR PATIENTS WITH NODE-POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY

Inclusion Criteria

•  Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
•  Any T-stage is eligible (AJCC 8th ed)
•  Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (including external iliacs, internal iliacs, and/or obturator nodes).

Exclusion Criteria

•  Definitive radiologic evidence of metastatic disease ((M1a, M1b or M1c) on molecular imaging (e.g. Fluciclovine F-18 PET, PSMA, F-18 choline 11)
•  Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)

• Cooperman Barnabas Medical Center