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.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor adult glioblastoma multiforme	Drug: gefitinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Henry S. Friedman, MD,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068639; DUMC-2421-03-2R2; DUMC-2421-01-2; NCI-1253
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00016991
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08