Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00016991


Primary Contact:

Study Chair
Henry S. Friedman, MD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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