Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma

• No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma

• Completed standard external beam radiotherapy within the past 2-5 weeks

• No evidence of tumor progression during radiotherapy

• Performance status - ECOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST no greater than 3 times ULN

• Creatinine no greater than 1.5 times ULN

• No other active malignancy

• No uncontrolled infection

• No other severe concurrent disease that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor

• See Disease Characteristics

• No prior stereotactic radiosurgery or interstitial brachytherapy

• No more than 15 weeks since prior surgery