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.
- Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first
- 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
- Histologically confirmed glioblastoma multiforme in first relapse
- 18 and over
- Karnofsky 60-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
- Creatinine less than 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- 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:
- Not specified
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
- Must be on stable dose of steroids for at least 1 week
- At least 4 weeks since prior radiotherapy and recovered
- At least 1 week since prior surgery
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV
- No concurrent enzyme-inducing anticonvulsant drugs