Trials / Unknown
UnknownNCT00004204
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Herbert Irving Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Detailed description
OBJECTIVES: * Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide. * Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme \[closed to accrual 11/30/01\] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | temozolomide |
Timeline
- Start date
- 2000-02-01
- First posted
- 2003-07-18
- Last updated
- 2014-01-06
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00004204. Inclusion in this directory is not an endorsement.