NCT00499473

Sunitinib in Treating Patients With Recurrent Malignant Gliomas

A Pharmacokinetic and Phase 2 Study of Sunitinib Malate in Recurrent Malignant Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy of sunitinib malate in patients with recurrent malignant gliomas as measured by 6-month progression-free survival. II. To determine the lower of the dose of sunitinib malate in patients receiving enzyme-inducing anti-convulsants that would achieve similar serum drug and metabolite concentrations as that in patients not receiving enzyme-inducing anticonvulsants or the maximum tolerated dose in the same population. SECONDARY OBJECTIVES: I. To examine the toxicity and safety of sunitinib malate in patients with the above noted tumors. II. To evaluate tumor responses in the stated patients. III. To evaluate progression-free and overall survival in the stated patients. OUTLINE: This is a multicenter study. Patients are stratified according to use of enzyme-inducing anticonvulsants (EIAC) (yes vs no). STRATUM 1 (non-EIAC): Patients receive oral sunitinib malate once daily for 4 consecutive weeks followed by 2 weeks of rest. STRATUM 2 (EIAC \& OSU patients only): Patients receive oral sunitinib malate as in stratum 1. Patients receive escalating doses of oral sunitinib malate until the maximum tolerated dose (MTD) is determined. Patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for plasma concentrations of sunitinib malate via LC/MS/MS method. In both strata, treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Diffuse Astrocytoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Pineal Gland Astrocytoma

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given orally
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-06-01
• Completion: 2014-10-01
• First posted: 2007-07-11
• Last updated: 2016-02-29
• Results posted: 2016-02-29

Locations

1 site across 1 country: United States