Clinical Trial Finder

Inclusion Criteria:

• - Signed informed consent.

• - Age >= 18 years.

• - Histologically confirmed GBM in first relapse.

• - Disease progression in those patients following prior implantation with Gliadel(R) wafer(s) (polifeprosan 20 with carmustine implant) must be confirmed by biopsy.

Prior therapy with Gliadel(R) is allowed only as a component of primary surgery. Patients with Gliadel(R) implants after a secondary resection are not eligible.

• - Radiographic evidence of disease progression, as assessed by the investigator, on magnetic resonance imaging (MRI) or CT scan.

• - Bi-dimensionally measurable disease with a minimum measurement of 1 cm on MRI or CT scan performed within 14 days prior to study entry.

• - Prior radiotherapy.

• - Availability of tissue to allow central confirmation of GBM diagnosis (all original slides are preferred) - Availability of paraffin blocks or slides to allow determination of EGFR amplification status.

• - Recovery from the toxic effects of a prior therapy, including 4 weeks from prior cytotoxic agents (except 6 weeks from prior nitrosoureas, 3 weeks from prior procarbazine administration, 2 weeks from prior vincristine, or 3 weeks from irinotecan [CPT-11] when given on a weekly schedule), 4 weeks from any prior investigational agent, and 1 week from prior non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, 13-cis-retinoic acid, etc.) - If receiving corticosteroids, patients must be on a stable, non-increasing dose of corticosteroids for >= 2 weeks prior to baseline MRI scan.

• - ECOG performance status of 0 or 1.

• - Life expectancy > 12 weeks.

• - Use of an effective means of contraception in males and in females of childbearing potential.

• - Ability to comply with study and follow-up procedures If the decision is made at the end of Stage 1 to enroll patients with tumors known to be positive for EGFR amplification, the following additional inclusion criteria will be applied: Confirmation of diagnosis; Confirmation of positive EGFR amplification status.

Exclusion Criteria:

• - Prior treatment with Gleevec (e.g., imatinib mesylate) or agents directed at EGFR (e.g., Iressa) - Prior treatment with Gliadel(R) following second (salvage or debulking) therapy.

• - History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix) - More than one prior chemotherapy regimen.

• - ANC < 1500/uL.

• - Platelets < 100,000/uL.

• - Total bilirubin > 1.6 mg/dL.

• - AST/ALT >= 2.5 x upper limit of normal (ULN) - Creatinine > 1.5 x ULN.

• - Pregnant or nursing females.

• - Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to study entry, or serious cardiac arrhythmia requiring medication.

• - Major surgical procedure 2 weeks prior to study entry or anticipation of need for major surgical procedure during the course of the study.

- Inability to take oral medication