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Primary Objective: To assess the effect of berubicin compared with lomustine on overall survival(OS) in adult patients with GBM (WHO Grade IV) that has recurred after standard initial therapy.
Protocol Number: 142101
Phase: Phase III
Scope: National
Applicable Disease Sites: Brain and Nervous System
Therapies Involved: Chemotherapy single agent systemic
Drugs Involved: Berubicin LOMUSTINE
Contacts:
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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.
1. (Dose-finding phase) To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). 2. (Efficacy phase) To estimate the event-free survival (EFS) distribution for DMG/HGG patients and overall survival (OS) distribution for DIPG patients associated with selinexor plus RT, followed by selinexor in patients with newly diagnosed HGG (H3 K27M-mutant DMG or H3 K27-wild type HGG) or DIPG, and to compare those outcomes to historical controls
Protocol Number: 112203
Principal Investigator: Scott Moerdler M.D.
Phase: Phase I/II
Therapies Involved: Radiotherapy Chemotherapy single agent systemic
Drugs Involved: Selinexor
1. To estimate the progression-free survival (PFS) of children +/-3 years of age with WNT-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gy) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable. 2. To prospectively test the hypothesis that DNA methylation profiling will accurately classify WNT-driven medulloblastoma. 3. To prospectively evaluate and longitudinally model the cognitive,social, emotional, behavioral and Quality of Life (QoL) functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine and CCNU) 4.To explore whether DNA methylation profiling of medulloblastoma samples will result in a predictive classification scheme for the Sonic Hedgehog (SHH) 5. To describe the audiologic and endocrinologic toxicities, as well as peripheral neuropathy in children treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced cisplatin and vincristine chemotherapy.
Protocol Number: 111708
Principal Investigator: Richard Drachtman M.D.
Phase: Phase II
Therapies Involved: Radiotherapy Chemotherapy multiple agents systemic
Drugs Involved: LOMUSTINE MESNA CISPLATIN CYCLOPHOSPHAMIDE G-CSF VINCRISTINE
1: To determine whether the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior to treatment with carboplatin/vincristine (CV) in previously untreated Neurofibromatosis type 1 (NF1)-associated low- grade glioma (LGG). 2: To determine whether visual acuity (VA) using Teller Acuity Cards (TAC), in patients with NF1-associated LGG within the optic pathway, is better in those treated with selumetinib. 3: To estimate tumor response rates and overall survival (OS) in each treatment regimen in previously untreated NF1-associated LGG. 4: To evaluate VA outcomes utilizing HOTV letter acuity testing in previously untreated NF1-associated LGG within the optic pathway in patients who are old enough to perform visual acuity testing utilizing HOTV (a recognition acuity measure). 5: To describe the improvement in motor function as measured by the Vineland scale in patients with previously untreated NF1-associated LGG that have documented motor deficits at enrollment. 6: To prospectively evaluate and compare the quality of life among patients treated with selumetinib or CV. 7: To prospectively evaluate and compare the cognitive, social, emotional, and behavioral functioning of patients with NF1-associated LGG treated with either selumetinib or CV. 8: To evaluate optical coherence tomography (OCT) measures of retinal axon and ganglion cell thickness as a marker of treatment response in previously untreated NF1-associated LGG within the optic pathway. 9: To compare novel, semi-automated volumetric MRI measures to traditional measurements of treatment response (bi-dimensional MRI measurements) in NF1- associated optic pathway tumors. 10: To obtain paired blood and tumor tissue to be banked for future NF1-LGG biology studies involving comprehensive molecular analysis, including but not limited to whole exome and RNA sequencing.
Protocol Number: 111914
Therapies Involved: Chemotherapy multiple agents systemic Chemotherapy single agent systemic
Drugs Involved: VINCRISTINE Selumetinib CARBOPLATIN
Primary Objective: - To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM (GBM) with MGMT promoter methylation. Secondary Objectives: - To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM (GBM) with MGMT promoter methylation. - To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation. - To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in PROs as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM (GBM) with MGMT promoter methylation. - To assess toxicity in the two different chemotherapy regimens.
Protocol Number: 142202
Therapies Involved: Radiotherapy
Drugs Involved: TEMOZOLOMIDE LOMUSTINE
Co-primary objectives To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment. Secondary objectives To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary craniopharyngiomas. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma. To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors Exploratory objectives To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. Correlative science objectives To evaluate molecular biomarkers of response in papillary craniopharyngiomas. To evaluate circulating tumor cells and cell-free circulating DNA in patients with papillary craniopharyngiomas.
Protocol Number: 141905
Principal Investigator: Pankaj Agarwalla
Therapies Involved: Chemotherapy (NOS)
Drugs Involved: Cobimetinib (Cotellic) vemurafenib (Zelboraf)