S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
NCT ID: NCT00016419
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2001-08-31
2007-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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anti-thymocyte globulin
3.5 mg/kg/d IV over 12 hrs day 1
cyclosporine
3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
Eligibility Criteria
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Inclusion Criteria
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
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Charles A. Schiffer, MD
Role: STUDY_CHAIR
Barbara Ann Karmanos Cancer Institute
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Genesis Medical Center
Davenport, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Oregon Cancer Institute
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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S0020
Identifier Type: OTHER
Identifier Source: secondary_id
S0020
Identifier Type: -
Identifier Source: org_study_id
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