Adult Brain Tumors Clinical Trial
Official title:
Phase-2 Study of Tarceva in Patients With Recurrent EGFR Positive and Phosphatase and Tensin Homolog (PTEN) Wild Type Glioblastoma Multiforme and Gliosarcoma
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
recurrent glioblastoma multiforme or gliosarcoma.
OBJECTIVES:
Primary
- Determine the objective response rate in patients with recurrent epidermal growth
factor receptor (EGFR)-positive and PTEN wild-type glioblastoma multiforme or
gliosarcoma treated with erlotinib hydrochloride.
Secondary
- Assess the response rate in patients who also EGFRVIII mutant and PTEN wild type
glioblastoma multiforme or gliosarcoma.
- Determine the progression-free survival of patients treated with this drug.
OUTLINE: This is an open-label study. Patients are stratified according to concurrent use of
enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no).
Patients receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats
every 4 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Some patients may receive additional erlotinib hydrochloride after 1 year at their
physician's discretion.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment