Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase III Randomized Evaluation of 13-Cis-Retinoic Acid (cRA) Plus Procarbazine Versus Procarbazine Alone in the Treatment of Patients With Recurrent Primary Malignant Gliomas
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.
OBJECTIVES: I. Determine whether the combination of isotretinoin and procarbazine can
improve time to progression and survival compared to procarbazine alone in patients with
recurrent malignant gliomas. II. Document the toxicity of these two regimens in these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive
procarbazine alone or in combination with isotretinoin. Arm I: Patients receive oral
procarbazine once daily on days 1-14 every 28 days. Oral isotretinoin is administered every
12 hours on days 15-28 every 28 days. Patient receive 6 courses of combined therapy, then
continue with oral isotretinoin alone on days 15-28 of each 28 day course, until disease
progression or unacceptable toxicity. Arm II: Patients receive procarbazine by mouth once
daily on days 1-14 followed by 2 weeks of rest. Patients receive a total of 6 courses of
treatment in the absence of disease progression and unacceptable toxicity. Patients are
followed until death.
PROJECTED ACCRUAL: This study will accrue a total of 194 patients (97 per treatment group).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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