Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Erlotinib Administered Every 72 Hours in Patients With Glioblastoma Multiforme With Pharmacokinetic/Pharmacodynamic Correlates
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
treating patients with progressive glioblastoma multiforme.
Status | Terminated |
Enrollment | 10 |
Est. completion date | March 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Progression -free survival will be measured by radographic response using RECIST critera. | 12 months | No |
Primary | Correlation between presence of the EGFRvIII mutation with treatment outcomes | 6 months | No |
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