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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003693 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: dolastatin 10 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 1999 |
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000066796, MDA-DM-98187, NCI-T98-0001 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003693 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Blast Crisis Chronic Myelomonocytic Leukemia Leukemia, Lymphoid Precancerous Conditions Leukemia, Myeloid, Acute Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Dolastatin 10 Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Antimitotic Agents Leukemia, Myeloid Recurrence Tubulin Modulators Leukemia, Myelogenous, Chronic, BCR-ABL Positive Anemia, Refractory, with Excess of Blasts Chronic Myelogenous Leukemia Bone Marrow Diseases |
|
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Mitosis Modulators Myelodysplastic Syndromes Myeloproliferative Disorders Antimitotic Agents Leukemia, Myeloid |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Tubulin Modulators Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Dolastatin 10 |
