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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00980343
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date February 2010
Completion date June 2012

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