Status:
TERMINATED
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of erlotinib hydrochloride when administered in escalating doses every 72 hours in patients with progressive glioblastoma multiforme. Seco...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme)
- Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy)
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- ANC \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 8.5 g/dL
- ALT and AST \< 2 times upper limit of normal (ULN)
- Alkaline phosphatase \< 2 times ULN
- Bilirubin \< 1.5 mg/dL
- Creatinine \< 1.5 mg/dL OR creatinine clearance \> 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diagnosis or history of significant renal or hepatic disease
- No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure
- No active infection
- No diagnosis or history of corneal abnormalities
- No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption
- No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00227032
Start Date
September 1 2005
End Date
March 1 2008
Last Update
March 6 2012
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295