Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
