ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme in first relapse

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 3,000/mm^3

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

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

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine less than 1.5 times ULN

Cardiovascular:

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other:

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No prior allergic reactions to compounds of similar chemical or biologic composition to ZD 1839

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Ocular inflammation must be fully treated before study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• Must be on stable dose of steroids for at least 1 week

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• At least 1 week since prior surgery

Other:

• No other concurrent investigational agents

• No other concurrent anticancer therapy

• No concurrent combination antiretroviral therapy for HIV

• No concurrent enzyme-inducing anticonvulsant drugs