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Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase

Phase 1
Not Enrolling
Leukemia, Myelodysplastic Syndromes

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Trial Information

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.

Inclusion 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Dolastatin

Outcome Description:

Maximum tolerated dose defined by dose limiting toxicity of dolastatin.

Outcome Time Frame:

Assessed with each 3 week cycle

Safety Issue:


Principal Investigator

Jorge Cortes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 1999

Completion Date:

October 2001

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • previously treated myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia



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