Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known whether SU-101 is more effective than
procarbazine in treating patients with glioblastoma multiforme.
PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of
procarbazine in treating patients with glioblastoma multiforme that has recurred.
OBJECTIVES: I. Compare the median survival of patients with glioblastoma multiforme in first
relapse treated with intravenous leflunomide (SU101) administered as a loading dose with
weekly maintenance therapy versus oral, single-agent procarbazine administered daily for 28
days every 56 days. II. Compare the median time to progression for these regimens in these
patients. III. Assess the objective response of these patients. IV. Assess the safety of
SU101 given on this schedule. V. Describe the health-related quality of life of these
patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to performance status (Karnofsky 60-80% vs 90-100%), age (less than 50 vs 50 and
over), and time from initial diagnosis to recurrence (6 months or greater vs less than 6
months). Patients are randomized to one of two treatment arms. Arm I: Patients receive
leflunomide (SU101) IV over 6 hours daily on days 1-4, again 4-8 days later, and weekly
thereafter for a total of 4 loading dose infusions and six maintenance infusions in course
1. Patients receive 7 weekly maintenance infusions of SU101 in courses thereafter. Treatment
repeats every 8 weeks. Arm II: Patients receive procarbazine orally once or twice daily for
4 weeks. Treatment is repeated every 8 weeks. All patients complete a health-related
quality-of-life questionnaire every 8 weeks and at study withdrawal. Treatment courses
continue up to a maximum of 1 year in the absence of unacceptable toxicity or disease
progression. Patients are followed every 2 months, beginning 30 days after study completion.
PROJECTED ACCRUAL: A maximum of 380 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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