S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00016419
First received: May 6, 2001
Last updated: January 12, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • total response [ Time Frame: after induction therapy is completed ] [ Designated as safety issue: No ]

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:
    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
Detailed Description:

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016419

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
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
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
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
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
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
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
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
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110
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
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
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
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
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
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
Oregon Cancer Institute
Portland, Oregon, United States, 97239
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
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
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
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
Investigators
Study Chair: Charles A. Schiffer, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00016419     History of Changes
Other Study ID Numbers: CDR0000068631, S0020, U10CA032102
Study First Received: May 6, 2001
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

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:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 23, 2014