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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005866 |
Purpose
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study) |
| Study Start Date: | June 2000 |
OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
Eligibility| Ages Eligible for Study: | 16 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Increased blasts (i.e., greater than 1 to 30% peripheral blood blasts and/or 5 to 30% bone marrow blasts) AND International Prognostic Score intermediate 1, intermediate 2, or high risk Refractory anemia with excess blasts OR Refractory anemia with excess blasts in transformation (no presence of auer rods as sole criteria) OR Chronic myelomonocytic leukemia Greater than 1% blasts in the peripheral blood and/or at least 5% blasts in the bone marrow OR MDS related acute myeloid leukemia Arising after documented MDS of at least 60 days Absolute peripheral blast count no greater than 5,000/mm3 Must have genotypically HLA identical sibling donor Must also be enrolled on SWOG-S9910 and SWOG-9007
PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No prior malignancy within past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission HIV negative Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) Endocrine therapy: Not specified Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia Surgery: Not specified
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85062-2989 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Northern California Cancer Specialists Medical Clinic | |
| Walnut Creek, California, United States, 94598 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| St. Joseph Hospital - Orange | |
| Orange, California, United States, 92613-5600 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Idaho | |
| Mountain States Tumor Institute | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Kansas | |
| Cancer Center of Kansas - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Lucille Parker Markey Cancer Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Louisiana State University School of Medicine | |
| New Orleans, Louisiana, United States, 70112-2822 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Memorial Medical Center | |
| New Orleans, Louisiana, United States, 70115 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Cancer Research Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| St. John's Health System | |
| Springfield, Missouri, United States, 65804 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Jewish Hospital of Cincinnati, Inc. | |
| Cincinnati, Ohio, United States, 45236 | |
| Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| Legacy Cancer Services | |
| Portland, Oregon, United States, 97210 | |
| Oregon Cancer Center | |
| Portland, Oregon, United States, 97201-3098 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Health Science Center | |
| Lubbock, Texas, United States, 79430 | |
| Methodist Health Care System | |
| San Antonio, Texas, United States, 78229 | |
| Scott and White Clinic | |
| Temple, Texas, United States, 76508 | |
| Texas Tech University Health Science Center | |
| Lubbock, Texas, United States, 79423 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| Wilford Hall - 59th Medical Wing | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Franciscan Health System | |
| Tacoma, Washington, United States, 98401-2197 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Jeanne E. Anderson, MD | Katmai Oncology Group |
More Information
| Study ID Numbers: | CDR0000067898, SWOG-S9920 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005866 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia |
secondary acute myeloid leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Precancerous Conditions Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclophosphamide Leukemia, Myeloid, Acute Cyclosporins Leukemia Preleukemia |
Pathologic Processes Antifungal Agents Therapeutic Uses Syndrome Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Enzyme Inhibitors Leukemia, Myeloid |
