Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of dolastatin
10 in patients with chronic myelogenous leukemia in blast phase, refractory or relapsed
acute leukemia, or myelodysplastic syndromes. II. Assess the possible antileukemia effect of
this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive dolastatin 10 intravenous (IV)
bolus once every 3 weeks. Patients receive 2-12 courses of therapy in the absence of disease
progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the
first cohort of 3 patients, subsequent cohorts of 3 patients each receive escalating doses
of dolastatin 10. If DLT occurs in 2 of 3 patients at a given dose level, then dose
escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients
are followed until death.
PROJECTED ACCRUAL: This study will accrue up to 25 patients within 8 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Dolastatin
Maximum tolerated dose defined by dose limiting toxicity of dolastatin.
Assessed with each 3 week cycle
Yes
Jorge Cortes, MD
Study Chair
M.D. Anderson Cancer Center
United States: Institutional Review Board
DM98-187
NCT00003693
March 1999
October 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |