Myelodysplastic Syndrome Clinical Trial
S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
Summary
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.
Full 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 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
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There are 86 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80010, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20060, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Davenport Iowa, 52804, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40502, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Royal Oak Michigan, 48073, United States
Southfield Michigan, 48075, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27104, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97207, United States
Portland Oregon, 97225, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
San Antonio Texas, 78284, United States
San Antonio Texas, 78284, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Seattle Washington, 98101, United States
Seattle Washington, 98108, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
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