NCT00980343

GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

A Biomarker and Phase II Study of GDC-0449 in Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	vismodegib	Given orally
PROCEDURE	therapeutic conventional surgery	undergo surgery
OTHER	laboratory biomarker analysis	correlative studies
OTHER	pharmacological study	correlative studies

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2009-09-21
• Last updated: 2017-08-16
• Results posted: 2017-08-16

Locations

9 sites across 1 country: United States