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Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome. Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome clinical trial. Participants frequently obtain the most expert healthcare available for their Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome  Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
For Condition: refractory anemia with ringed sideroblasts,de novo myelodysplastic syndromes,Refractory Anemia,refractory anemia with excess blasts,secondary myelodysplastic syndromes
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesSchiffer, Study Chair, Barbara Ann Karmanos Cancer Institute
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Additional Information:
Study ID Numbers: CDR0000068631; SWOG-S0020
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016419
Other Refractory Anemia With Excess Blasts Studies:
1. Decitabine in Treating Patients With Myelodysplastic Syndrome
2. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
3. Infliximab in Treating Patients With Myelodysplastic Syndrome
4. Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
5. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other refractory anemia with excess blasts Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
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