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
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
Maximum tolerated dose of becatecarin
Graded using the NCI CTCAE version 3.0.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|