Brain and Central Nervous System Tumors Clinical Trial
Official title:
Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme
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 nitrocamptothecin in treating patients
who have glioblastoma multiforme.
OBJECTIVES: I. Assess the therapeutic activity and toxicities of nitrocamptothecin in
patients with glioblastoma multiforme. II. Determine the overall response, duration of
response, and progression free survival of these patients after this treatment.
OUTLINE: This is a multicenter study. Patients receive nitrocamptothecin orally daily on
days 1-5. Treatment continues every 7 days in the absence of disease progression or
unacceptable toxicity. Patients are followed every 6 weeks until disease progression in the
absence of further treatment.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
;
Primary Purpose: Treatment
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