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S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myelodysplastic Syndromes

Intervention: anti-thymocyte globulin (Biological); cyclosporine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Charles A. Schiffer, MD, Study Chair, Affiliation: Barbara Ann Karmanos Cancer Institute

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.

Clinical Details

Official title: A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: total response

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

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona 85012, United States

Arizona Cancer Center, Tucson, Arizona 85724, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas 72205, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90033-0804, United States

Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California 90073, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

University of Colorado Cancer Center, Denver, Colorado 80010, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia 20060, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia 30905-5650, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813-2424, United States

Tripler Army Medical Center, Honolulu, Hawaii 96859-5000, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, United States

Loyola University Medical Center, Maywood, Illinois 60153-5500, United States

Genesis Medical Center, Davenport, Iowa 52804, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7353, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40502-2236, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71130, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts 02130, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0912, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

Veterans Affairs Medical Center - Albany, Albany, New York 12208, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Barrett Cancer Center, Cincinnati, Ohio 45267-0501, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-9001, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

CCOP - Columbia River Program, Portland, Oregon 97225, United States

Oregon Cancer Institute, Portland, Oregon 97239, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina 29401-5799, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234-6200, United States

University of Texas Medical Branch, Galveston, Texas 77555-0565, United States

Veterans Affairs Medical Center - Houston, Houston, Texas 77030, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7845, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78284, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112-5550, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Madigan Army Medical Center, Tacoma, Washington 98431-5000, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2001
Last updated: March 5, 2015

Page last updated: August 20, 2015

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