Myelodysplastic Syndrome Clinical Trial

Topotecan in Treating Patients With Myelodysplastic Syndrome

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of topotecan in treating patients who have myelodysplastic syndrome.

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Full Description

OBJECTIVES: I. Estimate complete or partial remission, hematologic improvement, and cytogenic response rate when oral topotecan is given twice a day for 5 days versus once a day for 10 days to patients with myelodysplastic syndromes. II. Evaluate the safety and toxicity of oral topotecan in these patients. III. Evaluate whether there are morphologic and/or cytogenetic subsets of the myelodysplastic syndromes that will respond optimally to this regimen. IV. Evaluate the change in the percentage of bone marrow blast cells in these patients during treatment. V. Evaluate the time to transformation to acute myeloid leukemia (AML) or death in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to FAB subtype: 1. Refractory anemia with excess blasts 2. Refractory anemia with excess blasts in transformation 3. Chronic myelomonocytic leukemia 4. Refractory anemia, refractory anemia with ringed sideroblasts, and refractory cytopenia with multilineage dysplasia Patients are randomized to receive oral topotecan either twice daily for 5 days or once daily for 10 days. Courses are repeated every 21 days. Patients are evaluated for hematologic response after the initial 2 courses, and then every 4 courses. If a partial response or hematologic improvement is observed, treatment continues until disease progression to acute myeloid leukemia, relapse, death, or irreversible toxicity. Patients who achieve a complete response receive an additional 2 courses of therapy before discontinuation of protocol treatment. Patients are followed every 3 months for 2 years, then every year for an additional 3 years, and at time of progression.

PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study within 13 months.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Primary or therapy-related myelodysplastic syndrome: Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia Refractory anemia, refractory anemia with ringed sideroblasts, or refractory cytopenia with multilineage dysplasia These patients must also have one of the following criteria: Greater than 4 units of RBCs transfused within the past 3 months OR Platelet count less than 50,000/mm3 OR Neutrophil count less than 1,000/mm3 AND a recent infection requiring antibiotics

PATIENT CHARACTERISTICS: Age: Over 15 Performance status: 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Free of any evidence of prior cancer for at least 12 months

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior interferon No prior hematopoietic growth factors or cytokines except epoetin alfa No concurrent epoetin alfa Chemotherapy: No prior topotecan No prior chemotherapy for this disease At least 12 months since prior chemotherapy for another disease No other concurrent chemotherapy Endocrine therapy: At least 1 month since prior corticosteroids No concurrent hormonal therapy for disease-related conditions Concurrent steroids for adrenal failure allowed No concurrent dexamethasone and other steroidal antiemetics Radiotherapy: No prior radiotherapy for this disease At least 12 months since prior radiotherapy for another disease Surgery: Not specified Other: No prior cytotoxic therapy (including low-dose antimetabolites) for this disease At least 1 month since prior retinoids

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00003675

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 43 Locations for this study

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Veterans Affairs Medical Center - Birmingham
Birmingham Alabama, 35233, United States
University of California San Diego Cancer Center
La Jolla California, 92093, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Illinois at Chicago Health Sciences Center
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Louis A. Weiss Memorial Hospital
Chicago Illinois, 60640, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Veterans Affairs Medical Center - Togus
Togus Maine, 04330, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13210, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Veterans Affairs Medical Center - Memphis
Memphis Tennessee, 38104, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38163, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
Veterans Affairs Medical Center - Richmond
Richmond Virginia, 23249, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT00003675

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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