Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
