Spots Global Cancer Trial Database for GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Study Description

Brief Summary: This randomized phase II trial is studying how well GDC-0449 works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. GDC-0449 may be effective in treating patients with glioblastoma multiforme.

Detailed Description: PRIMARY OBJECTIVES: I. 6-month progression-free survival (PFS-6) measured from start of treatment following surgery. SECONDARY OBJECTIVES: I. Toxicity. (Clinical) II. Overall survival. (Clinical) III. Tumor response. Partial Response (PR) + Complete Response (CR): MacDonald criteria). (Clinical) Correlative Studies * Determination of in vivo drug effect in recurrent Glioblastoma Multiform (GBM). (Correlative studies) * Determination of in vitro drug effect on CD133+ glioma-derived neurospheres. (Correlative studies) * Determination of Sonic Hedgehog pathway activation in primary vs. recurrent GBM. (Correlative studies) TERTIARY OBJECTIVES: I. Correlate clinical outcome (6 mo PFS) with biologic correlates (1-3) above. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral Hedgehog antagonist GDC-0449 once daily for 7 days before surgery. Arm II: Patients do not receive treatment before surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Fresh and paraffin-embedded tissue samples are collected for correlative laboratory studies. After completion of study treatment, patients are followed up every 2 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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