Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Study of Obatoclax (Pan Anti-Apoptotic BCL-2 Family Small Molecule Inhibitor), in Combination With Vincristine/Doxorubicin/Dexrazoxane, in Children With Relapsed/Refractory Solid Tumors or Leukemia
This phase I trial is studying the side effects and best dose of obatoclax mesylate when given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma, or leukemia. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth and causing the cells to self-destruct. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with combination chemotherapy may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase II dose of
obatoclax (obatoclax mesylate) administered as a single agent on day 1 and in combination
with vincristine ( vincristine sulfate), doxorubicin (doxorubicin hydrochloride), and
dexrazoxane (dexrazoxane hydrochloride) at day 8 in children with refractory solid tumors.
II. To define and describe the toxicities of obatoclax administered on this schedule.
III. To characterize the pharmacokinetics of obatoclax in children with refractory solid
tumors or relapsed leukemia.
SECONDARY OBJECTIVES:
I. To preliminarily define the antitumor activity of obatoclax in children with refractory
or relapsed solid tumors and leukemias within the confines of a Phase I study.
II. To preliminarily assess leukemic blast characteristics associated with obatoclax
activity.
III. To preliminarily assess the biological activity of obatoclax by investigating effects
on cell death regulatory pathways.
OUTLINE: This is a dose-escalation study of obatoclax mesylate.
STRATUM 1 (dose-escalation): Patients receive obatoclax mesylate intravenously (IV) over 3
hours on days 1 and 8 and vincristine sulfate IV, doxorubicin hydrochloride IV, and
dexrazoxane hydrochloride IV on day 8 of course 1 (28 days). Drugs are administered on day 1
of subsequent courses and repeat every 21 days for up to 1 year in the absence of disease
progression or unacceptable toxicity.
STRATUM 2: Patients receive obatoclax mesylate (at starting dose in stratum 1), vincristine
sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride as in stratum 1.
STRATUM 3: Patients receive obatoclax mesylate (at the MTD determined in stratum 1),
vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride as in stratum
1.
After completion of study therapy, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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