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 myelodysplastic syndrome.

Condition	Treatment or Intervention	Phase
Previously Treated Myelodysplastic Syndrome recurrent adult acute myeloid leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia Chronic Myelomonocytic Leukemia blastic phase chronic myelogenous leukemia	Drug: dolastatin 10	Phase I

Further Study Details: 

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.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive dolastatin 10 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--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 leukemia)

--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

--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

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Jorge Cortes,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000066796; MDA-DM-98187; NCI-T98-0001
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003693
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08