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S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00016419
First received: May 6, 2001
Last updated: March 5, 2015
Last verified: March 2015
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Purpose
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
| Leukemia Myelodysplastic Syndromes | Biological: anti-thymocyte globulin Drug: cyclosporine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
MedlinePlus related topics:
Myelodysplastic Syndromes
Genetic and Rare Diseases Information Center resources:
Myelodysplastic Syndromes
Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- total response [ Time Frame: after induction therapy is completed ]
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2001 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: anti-thymocyte globulin
3.5 mg/kg/d IV over 12 hrs day 1
Drug: cyclosporine
3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
OBJECTIVES:
- Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine.
- Determine the frequency and severity of toxic effects of this regimen in these patients.
- Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts).
Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia [RA], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.
Eligibility| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Morphologically confirmed myelodysplastic syndromes (MDS)
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts
- Low, intermediate-1, or intermediate-2 risk by International Prognostic Scoring System criteria
- MDS secondary to prior chemotherapy and/or radiotherapy for other malignant disorders allowed
- Must have received prior transfusions of at least 4 units of red blood cells for anemia within the past 60 days
- Must be concurrently registered on SWOG-S9910 and SWOG-9007
- Ineligible for or refused participation in SWOG-S9920 (HLA-identical sibling peripheral blood stem cell transplantation)
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or 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:
- See Disease Characteristics
- Prior cytokines (e.g., interferon or interleukin), colony-stimulating factors, or epoetin alfa allowed
- No prior bone marrow or stem cell transplantation
- No concurrent growth factors (including epoetin alfa) except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenia
Chemotherapy:
- See Disease Characteristics
- No prior remission induction chemotherapy for MDS
- Prior hydroxyurea allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- Prior amifostine allowed
- No calcium-channel blockers (diltiazem, nicardipine, or verapamil), antifungals (fluconazole, itraconazole, or ketoconazole), antibiotics (clarithromycin or erythromycin), or other drugs (bromocriptine or danazol) that would increase cyclosporine concentrations for 48 hours before, during, and for 48 hours after cyclosporine
- No antibiotics (nafcillin or rifampin) or anticonvulsants (carbamazepine, phenobarbital, or phenytoin) that would decrease cyclosporine concentrations for 14 days before and during cyclosporine
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016419
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00016419
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Locations
| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock (McClellan) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813-2424 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| United States, Iowa | |
| Genesis Medical Center | |
| Davenport, Iowa, United States, 52804 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Louisiana | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| United States, Mississippi | |
| Veterans Affairs Medical Center - Biloxi | |
| Biloxi, Mississippi, United States, 39531-2410 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| United States, Missouri | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97225 | |
| Oregon Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Veterans Affairs Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7845 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78284 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Charles A. Schiffer, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00016419 History of Changes |
| Other Study ID Numbers: |
S0020 S0020 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| Study First Received: | May 6, 2001 |
| Last Updated: | March 5, 2015 |
Keywords provided by Southwest Oncology Group:
|
refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts |
de novo myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Cyclosporins Cyclosporine |
Antilymphocyte Serum Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |
ClinicalTrials.gov processed this record on August 22, 2017