Trials / Completed
CompletedNCT00005954
Temozolomide in Treating Patients With Brain Metastases
Phase II Treatment of Adults With Brain Metastases With Temodar
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Duke University · 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 brain metastases.
Detailed description
OBJECTIVES: * Determine the activity of temozolomide in patients with brain metastases. * Determine the toxicity of this treatment in these patients. OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other). Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | temozolomide |
Timeline
- Start date
- 2000-08-01
- Completion
- 2003-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005954. Inclusion in this directory is not an endorsement.