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Lead
Duke University
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse