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Study Title Principal Investigator
10M-14-4 Phase III, Randomized, Double-Blind, Multicenter Trial Of Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells (NBS20) Vs. Autologous Peripheral Blood Mononuclear Cell Control (MC), Both Coadministered With Adjuvant GM-CSF, For The Treatment Of Patients With Metastatic Melanoma
Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.
Terminated | Skin Cancer | Multisite
Michael Wong
| Skin Cancer | Site Unknown
James Hu
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| Gynecologic Cancers | Multisite
Antoni Ribas
10M-12-3 Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma
Active, not recruiting | Skin Cancer | Site Unknown
Michael Wong
10M-13-1 A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment versus Chemotherapy for Subjects with Advanced Melanoma who Progressed after Initially Achieving Disease Control with Ipilimumab Therapy
Terminated | Skin Cancer | Multisite
Michael Wong
CTSU/CALGB A021202: Prospective Randomized Phase II Trial Of Pazopanib (NSC # 737754, IND 75648) Versus Placebo In Patients With Progressive Carcinoid Tumors
PRIMARY OBJECTIVES: I. For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) will be compared between patients randomized to treatment with pazopanib (pazopanib hydrochloride) versus placebo. SECONDARY OBJECTIVES: I. Overall survival will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms. III. Progression free survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms. IV. PFS at 6 months and 12 months will be estimated within each treatment arm. V. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm. VI. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA. VII. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo. TERTIARY OBJECTIVES: I. Average time to submission of scans to the Imaging Core Laboratory (ICL) and average ICL "turn-around" time will be estimated. II. Discordance between the local and central radiology review in assessment of progression will be estimated. III. The rates and quality of radiographic progression (pre-study, on-study, and post-progression) will be characterized. IV. To assess for differences in quality of life (QOL)-related domains between the two treatment groups (pazopanib versus placebo). V. To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (European Organization for Research and Treatment of Cancer [EORTC], neuroendocrine tumors [NET]21). VI. To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. After completion of study treatment, patients are followed up every 3-6 months for 5 years.
Active, not recruiting | Neuroendocrine Tumors | Multisite
Syma Iqbal
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A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. SECONDARY OBJECTIVES: I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine. V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Active, not recruiting | Neuroendocrine Tumors | Multisite
Pamela Kunz
0S-12-1-A Randomized, Double-Blind, Multicenter, Phase III Study of Everolimus (RAD001) plus Best Supportive Care versus Placebo plus Best Supportive Care in the Treatment of Patients with Advanced NET of GI or Lung Origin - RADIANT-4
Active, not recruiting | Neuroendocrine Tumors | Multisite
Syma Iqbal
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0S-14-3: Phase II Study of Single Agent Regorafenib in Patients with Advanced/Metastatic Neuroendocrine Tumors
The primary objective of this study is to assess Progression free survival in advanced/metastatic patients with carcinoid or pancreatic islet cell tumorsNeuroendocrine tumors, which include carcinoid tumors and pancreatic islet cell tumors, are rare malignancies. Regorafenib is a multiple kinase inhibitor targeting several receptor tyrosine kinases that are involved in tumor progression. In addition, regorafenib blocks VEGF dependent kinase activation. Hence, Regorafenib is being studied as a potential treatment of neuroendocrine tumors as a single agent.Regorafenib 160 mg qd will be administered for 3 weeks on /1 week off. Participants may remain on study until the development of disease, development of intolerable toxicity, or any of the criteria for removal of the study as set forth in the protocol.The 6-month progression free survival rate will be the primary endpoint. Two parallel Simons 2-stage phase II trials will be conducted to evaluate the efficacy of regorafenib.
Not yet recruiting | Neuroendocrine Tumors | Multisite
Syma Iqbal
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10M-14-1: A 2 part Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma
Active, not recruiting | Skin Cancer | Multisite
Michael Wong
0C-15-2: STARTRK-2 (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases-2) An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
| Brain Cancer | Multisite
Barbara Gitlitz
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