Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
This phase I trial is studying the side effects and best dose of rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer cells from dividing so they stop growing or die
OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue
(XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic
syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase.
OUTLINE: This is a dose-escalation study.
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response (CR) receive 1 additional course beyond CR. Patients achieving
a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond
PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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