Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of AT-101 in Recurrent Extensive Stage Small Cell Lung Cancer
This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
I. To determine the objective response rate of R-(-)-gossypol in patients with recurrent
chemotherapy-sensitive extensive stage small cell lung cancer.
II. To determine the time to disease progression. III. To determine the overall survival.
IV. To assess the toxicities associated with this drug. V. To explore whether intratumoral
Bcl-2 family member expression correlates with sensitivity to targeting by R-(-)-gossypol.
VI. To explore whether the administration of R-(-)-gossypol causes specific induction of the
intrinsic apoptotic pathway.
OUTLINE: This is a multicenter study.
Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during treatment for pharmacodynamic analysis. Peripheral
blood mononuclear cells are analyzed via protein isolation and western blotting for Bcl-2,
cytoplasmic release of cytochrome c, and caspase activation. Available tumor tissue blocks
are assessed by immunohistochemistry.
After completion of study therapy, patients are followed periodically for up to 5 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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