Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study of BAY 43-9006 (NSC 724772) in Patients With Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
This randomized phase I trial is studying the side effects and best dose of two different schedules of sorafenib in treating patients with refractory or relapsed acute leukemia, myelodysplastic syndromes, or blastic phase chronic myelogenous leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of sorafenib when administered in two different
schedules in patients with refractory or relapsed acute leukemia, myelodysplastic syndromes,
or blastic phase chronic myelogenous leukemia.
II. Determine the dose-limiting toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug in these patients. II. Determine the
biologic effect of this drug in these patients.
OUTLINE: This is a randomized, dose-escalation phase I study. Patients are randomized to 1
of 2 treatment arms.
Arm I: Patients receive oral sorafenib once or twice daily on days 1-5, 8-12, and 15-19.
Arm II: Patients receive oral sorafenib once or twice daily on days 1-14.
In both arms, treatment repeats every 21 days for up to 6 months in the absence of disease
progression or unacceptable toxicity. Patients achieving complete remission or partial
remission after 6 months may continue therapy at the discretion of the principal
investigator.
In both arms, cohorts of 3-6 patients receive escalating doses of sorafenib 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. Up to 10 patients are
treated at the MTD.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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