Adult Glioblastoma Clinical Trial
Official title:
A Phase 2 Study of R-(-)-Gossypol (Ascenta's AT-101) in Recurrent Glioblastoma Multiforme
This phase II trial is studying how well gossypol works in treating patients with progressive or recurrent glioblastoma multiforme. Gossypol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the overall survival rate associated with AT-101 in treating adult patients
with recurrent glioblastoma multiforme.
SECONDARY OBJECTIVES:
I. To assess and estimate the acute and late toxicities. II. Tumor response rate. III. To
estimate 6-month progression free survival. IV. To explore associations of the clinical
outcome (overall survival) among the changes of potential serum biomarkers, baseline tumor
protein expression and gene methylation status.
OUTLINE: This is a multicenter study.
Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection at baseline and periodically
during study for biomarker correlative studies. Archived tumor tissue samples, if available,
are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and
BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are
analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
After completion of study therapy, patients are followed every 2 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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