Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas
NCT00003564 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2012-02-22
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.
Conditions
Interventions
- DRUG
-
Isotretinoin
Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
- DRUG
-
Procarbazine Hydrochloride
Arm I: Oral procarbazine once daily on days 1-14 every 28 days for 6 courses of combined therapy. Arm II: Oral procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Kurt A. Jaeckle, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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