ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse. Determine the pharmacokinetics and toxicity of this drug in these patients. Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug. OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 6 months. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.

Official Title
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A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma