Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I/II Study of Obatoclax Mesylate (GX15-070MS), a Bcl-2 Antagonist, Plus Topotecan in Relapsed Small Cell Lung Carcinoma
This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help kill more tumor cells
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose, recommended phase II dose, and toxicity profile of
obatoclax mesylate when administered with topotecan hydrochloride in patients with advanced
solid tumors. (Phase I) II. Determine the response rate in patients with relapsed or
refractory small cell lung cancer treated with obatoclax mesylate and topotecan
hydrochloride. (Phase II)
SECONDARY OBJECTIVES:
I. Evaluate the expression of pro- and anti-apoptotic proteins which may correlate with
obatoclax mesylate sensitivity or resistance.
OUTLINE: This is a phase I dose-escalation study of obatoclax mesylate followed by a phase
II study.
PHASE I (solid tumor): Patients receive obatoclax mesylate IV over 3 hours on day 1 OR days
1 and 3 and topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 3
weeks in the absence of disease progression or unacceptable toxicity.
PHASE II (small cell lung cancer): Patients receive obatoclax mesylate and topotecan
hydrochloride at the recommended phase II dose (RPTD) determined in phase I. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples from patients with small cell lung cancer may be collected at baseline
for correlative studies. Tissue samples are analyzed for biomarkers and protein expression
of Bcl-2, Bcl-Xl, MCL-1, Bax, Bad, c-Myc, L-Myc, and N-Myc by immunohistochemistry.
After completion of study treatment, patients are followed for 30 days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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