Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in treating patients with progressive glioblastoma multiforme.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme)

• Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• ANC > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 8.5 g/dL

• ALT and AST < 2 times upper limit of normal (ULN)

• Alkaline phosphatase < 2 times ULN

• Bilirubin < 1.5 mg/dL

• Creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No diagnosis or history of significant renal or hepatic disease

• No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure

• No active infection

• No diagnosis or history of corneal abnormalities

• No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption

• No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics