Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy.

PURPOSE: This phase I/II trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Carmustine; Irinotecan

Criteria

• 18 years and older

• Histologically confirmed newly diagnosed grade IV astrocytoma or gliosarcoma

• No oligodendrogliomas/oligoastrocytomas

• Study entry must occur within 8 weeks after surgery

• Performance status - ECOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 130,000/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 2 times ULN

• Creatinine ≤ 0.5 mg/dL above ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No other concurrent malignant disease except superficial skin cancers

• No other major medical problems

• No prior chemotherapy

• No prior radiotherapy for any tumor