Sunitinib in Treating Patients With Recurrent or Unresectable Meningioma Intracranial Hemangiopericytoma or Intracranial Hemangioblastoma
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- STATUS
- Recruiting
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- participants needed
- 50
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- sponsor
- Memorial Sloan-Kettering Cancer Center
Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying sunitinib to see how well it works in treating patients with recurrent or unresectable meningioma, intracranial hemangiopericytoma, or intracranial hemangioblastoma.
Description
OBJECTIVES: Primary - To evaluate the activity of sunitinib malate in patients with recurrent meningioma as measured by 6-month progression-free survival. Secondary - To describe the response rate, median time-to-progression, and overall survival in these patient. - To evaluate the safety of sunitinib malate in patients with recurrent meningioma. Exploratory - To develop exploratory data correlating response to the molecular phenotype of the tumor. - To develop exploratory data correlating serum angiogenic peptides, circulating endothelial cells (CEC) and circulating progenitor cells (CEP), and Dynamic Contrast Enhanced (DCE)-MRI with outcomes. OUTLINE: This is a multicenter study. Patients are stratified according to histology (benign vs malignant) and whether or not they have neurofibromatosis type 2 (yes vs no). Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month and then periodically thereafter. PROJECTED ACCRUAL: A total of 50 patients (40 patients with meningioma and 10 patients with hemangiopericytomas/hemangioblastomas) will be accrued for this study.
Details
| Condition | Brain and Central Nervous System Tumors, Neurofibromatosis Type 1, Neurofibromatosis Type 2, Precancerous Condition |
|---|---|
| Treatment | sunitinib malate |
| Clinical Study Identifier | NCT00561665 |
| Sponsor | Memorial Sloan-Kettering Cancer Center |
| Last Modified on | 7 November 2020 |
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