Clinical Trials - RWJBarnabas Health

2022-09-10 02:12:39 By : Ms. Tele Mall

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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.

Applicable Disease Sites: Brain and Nervous System

Drugs Involved: vemurafenib (Zelboraf) Cobimetinib (Cotellic)

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: 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.

Principal Investigator: Richard Drachtman M.D.

Applicable Disease Sites: Brain and Nervous System

Therapies Involved: Chemotherapy multiple agents systemic Chemotherapy single agent systemic

Drugs Involved: CARBOPLATIN Selumetinib VINCRISTINE

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.

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).

Applicable Disease Sites: Brain and Nervous System

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. 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.

Principal Investigator: Richard Drachtman M.D.

Applicable Disease Sites: Brain and Nervous System

Therapies Involved: Chemotherapy multiple agents systemic Radiotherapy

Drugs Involved: CYCLOPHOSPHAMIDE LOMUSTINE MESNA G-CSF VINCRISTINE CISPLATIN

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.

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.

Applicable Disease Sites: Brain and Nervous System

Therapies Involved: Chemotherapy single agent systemic

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.

Primary Objective Phase II: To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs progression-free survival (PFS) versus adding temozolomide to radiotherapy in patients with newly diagnosed glioblastoma (GBM) without MGMT promoter methylation Phase III: To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs overall survival (OS) versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation Secondary Objectives: To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs PFS versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation for the phase III part of the study. To determine if adding ipilimumab and nivolumab to radiotherapy significantly increases the 2-year OS rate versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation To evaluate the safety of adding ipilimumab and nivolumab to radiotherapy via comparative frequency between arms of specific adverse events of interest and frequency summaries for all adverse event types. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on patient reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM without MGMT promoter methylation. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on selected PRO-CTCAE items in patients with newly diagnosed GBM without MGMT promoter methylation. To evaluate the impact of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on neurocognitive function (NCF) in patients with newly diagnosed GBM without MGMT promoter methylation.

Applicable Disease Sites: Brain and Nervous System

Therapies Involved: Radiotherapy Chemotherapy multiple agents systemic

Drugs Involved: Opdivo (Nivolumab) TEMOZOLOMIDE IPILIMUMAB (MDX-010)

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.

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.

Applicable Disease Sites: Brain and Nervous System

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.

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