Spots Global Cancer Trial Database for Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme

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Trial Identification

Brief Title: Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme

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

Study ID: NCT00005826

Conditions

Brain and Central Nervous System Tumors

Interventions

rubitecan

Study Description

Brief Summary: 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.

Detailed Description: 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.