Trials / Terminated
TerminatedNCT00014443
Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.
Detailed description
OBJECTIVES: * Determine tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide. * Determine safety and tolerance of this regimen in these patients. OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | thalidomide | |
| DRUG | topotecan hydrochloride |
Timeline
- Start date
- 2000-08-01
- Primary completion
- 2003-08-01
- Completion
- 2003-12-01
- First posted
- 2003-01-27
- Last updated
- 2023-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00014443. Inclusion in this directory is not an endorsement.