Adult Glioblastoma Clinical Trial
Official title:
A Biomarker and Phase II Study of GDC-0449 in Patients With Recurrent Glioblastoma Multiforme
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.
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.
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