• Overview
  • Eligibility
  • More info
  • Locations

A Randomized Phase II Trial of Oral Topotecan Given Twice a Day for 5 Days or Once a Day for 10 Days to Patients With Myelodysplastic Syndromes (MDS) (NCT00003675)

National Cancer Institute (NCI)
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.
  • Drug: topotecan hydrochloride
    1.2 mg/sq m twice a day for 5 days (Arm I) and once a day for 10 days (Arm II)
    Ages eligible for Study
    15 Years to 120 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    48 locations

    United States (48)
    • Veterans Affairs Medical Center - Birmingham
      Birmingham, Alabama, United States, 35233
    • University of California San Diego Cancer Center
      La Jolla, California, United States, 92093-0658
    • UCSF Cancer Center and Cancer Research Institute
      San Francisco, California, United States, 94115-0128
    • Veterans Affairs Medical Center - San Francisco
      San Francisco, California, United States, 94121
    • CCOP - Christiana Care Health Services
      Wilmington, Delaware, United States, 19899
    • Vincent T. Lombardi Cancer Research Center, Georgetown University
      Washington, District of Columbia, United States, 20007
    • Walter Reed Army Medical Center
      Washington, District of Columbia, United States, 20307-5000
    • CCOP - Mount Sinai Medical Center
      Miami Beach, Florida, United States, 33140
    • University of Illinois at Chicago Health Sciences Center
      Chicago, Illinois, United States, 60612
    • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      Chicago, Illinois, United States, 60612
    • University of Chicago Cancer Research Center
      Chicago, Illinois, United States, 60637
    • Louis A. Weiss Memorial Hospital
      Chicago, Illinois, United States, 60640
    • University of Iowa Hospitals and Clinics
      Iowa City, Iowa, United States, 52242
    • Veterans Affairs Medical Center - Togus
      Togus, Maine, United States, 04330
    • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
      Baltimore, Maryland, United States, 21201
    • Dana-Farber Cancer Institute
      Boston, Massachusetts, United States, 02115
    • University of Massachusetts Memorial Medical Center
      Worcester, Massachusetts, United States, 01655
    • Veterans Affairs Medical Center - Minneapolis
      Minneapolis, Minnesota, United States, 55417
    • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      Columbia, Missouri, United States, 65201
    • Ellis Fischel Cancer Center - Columbia
      Columbia, Missouri, United States, 65203
    • Barnes-Jewish Hospital
      Saint Louis, Missouri, United States, 63110
    • University of Nebraska Medical Center
      Omaha, Nebraska, United States, 68198-3330
    • CCOP - Southern Nevada Cancer Research Foundation
      Las Vegas, Nevada, United States, 89106
    • Norris Cotton Cancer Center
      Lebanon, New Hampshire, United States, 03756
    • Veterans Affairs Medical Center - Buffalo
      Buffalo, New York, United States, 14215
    • Roswell Park Cancer Institute
      Buffalo, New York, United States, 14263-0001
    • CCOP - North Shore University Hospital
      Manhasset, New York, United States, 11030
    • North Shore University Hospital
      Manhasset, New York, United States, 11030
    • Memorial Sloan-Kettering Cancer Center
      New York, New York, United States, 10021
    • New York Presbyterian Hospital - Cornell Campus
      New York, New York, United States, 10021
    • Mount Sinai Medical Center, NY
      New York, New York, United States, 10029
    • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      Syracuse, New York, United States, 13210
    • State University of New York - Upstate Medical University
      Syracuse, New York, United States, 13210
    • Veterans Affairs Medical Center - Syracuse
      Syracuse, New York, United States, 13210
    • Lineberger Comprehensive Cancer Center, UNC
      Chapel Hill, North Carolina, United States, 27599-7295
    • Veterans Affairs Medical Center - Durham
      Durham, North Carolina, United States, 27705
    • Duke Comprehensive Cancer Center
      Durham, North Carolina, United States, 27710
    • CCOP - Southeast Cancer Control Consortium
      Winston-Salem, North Carolina, United States, 27104-4241
    • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      Winston-Salem, North Carolina, United States, 27157-1082
    • Arthur G. James Cancer Hospital - Ohio State University
      Columbus, Ohio, United States, 43210
    • Rhode Island Hospital
      Providence, Rhode Island, United States, 02903
    • Medical University of South Carolina
      Charleston, South Carolina, United States, 29425-0721
    • Veterans Affairs Medical Center - Memphis
      Memphis, Tennessee, United States, 38104
    • University of Tennessee, Memphis Cancer Center
      Memphis, Tennessee, United States, 38163
    • Vermont Cancer Center
      Burlington, Vermont, United States, 05401-3498
    • Veterans Affairs Medical Center - White River Junction
      White River Junction, Vermont, United States, 05009
    • Veterans Affairs Medical Center - Richmond
      Richmond, Virginia, United States, 23249
    • MBCCOP - Massey Cancer Center
      Richmond, Virginia, United States, 23298-0037
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1999
    Updated:
    18 July, 2016
    Participants:
    100
    A girl giving information about available additional trials.

    FindMeCure helps you find, understand and join clinical trials from all over the world.

    There are more clinical trials for your condition!