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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 43 Locations for this study
Birmingham Alabama, 35233, United States
La Jolla California, 92093, United States
San Francisco California, 94115, United States
San Francisco California, 94121, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Iowa City Iowa, 52242, United States
Togus Maine, 04330, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Minneapolis Minnesota, 55417, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Buffalo New York, 14215, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38104, United States
Memphis Tennessee, 38163, United States
Burlington Vermont, 05401, United States
White River Junction Vermont, 05009, United States
Richmond Virginia, 23249, United States
Richmond Virginia, 23298, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.