Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Leukemia |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/27/2018 |
Start Date: | December 18, 1998 |
End Date: | October 30, 2001 |
Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
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.
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.
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.
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
leukemia)
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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