RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who
have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or
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.
DISEASE CHARACTERISTICS: Histologically diagnosed chronic myelogenous leukemia in blastic
phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes (refractory
anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic
PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT
no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL
OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile
patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy and recovered (unless evidence of rapid disease progression)
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified