Trials / Completed
CompletedNCT00093613
Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma
A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of BAY 43-9006 when administered to adults with recurrent malignant glioma, receiving (Group A) or not receiving (Group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. II. To assess and estimate the dose-related toxicities. III. To describe the pharmacokinetics of this route of administration, measuring BAY 43-9006, and to assess the pharmacokinetic difference between patients taking enzyme-inducing agents and those who are not. IV. To estimate overall survival. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to the concurrent use of cytochrome P450-inducing anticonvulsants (yes vs no). Patients receive oral sorafenib twice daily on days 1-28 (once daily on day 1 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months.
Conditions
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Oligodendroglioma
- Adult Giant Cell Glioblastoma
- Adult Gliosarcoma
- Recurrent Adult Brain Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sorafenib tosylate | Given PO |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2010-10-01
- Completion
- 2011-12-01
- First posted
- 2004-10-08
- Last updated
- 2014-05-30
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00093613. Inclusion in this directory is not an endorsement.