Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Chronic Myeloid Leukemia Leukemia Myelodysplastic Syndromes

Drug Information available for: Dolastatin 10

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) of Dolastatin [ Time Frame: Assessed with each 3 week cycle ] [ Designated as safety issue: Yes ]
Maximum tolerated dose defined by dose limiting toxicity of dolastatin.

Enrollment:	30
Study Start Date:	March 1999
Study Completion Date:	October 2001
Primary Completion Date:	October 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MTD Group	Drug: Dolastatin 10 IV bolus once every 3 weeks.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003693

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jorge Cortes, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jorge Cortes, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00003693 History of Changes
Other Study ID Numbers:	DM98-187, U01CA062461, P30CA016672, MDA-DM-98187, NCI-T98-0001, CDR0000066796
Study First Received:	November 1, 1999
Last Updated:	March 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

Precancerous Conditions
Dolastatin 10
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012