ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal