A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)
Phase 2
15 Years
N/A
15 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes
Both
Leukemia, Myelodysplastic Syndromes
Trial Information
A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
total response
Outcome Time Frame:
after induction therapy is completed
Safety Issue:
No
Principal Investigator
Charles A. Schiffer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068631
NCT ID:
NCT00016419
Start Date:
August 2001
Completion Date:
January 2007
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- refractory anemia
- refractory anemia with ringed sideroblasts
- refractory anemia with excess blasts
- de novo myelodysplastic syndromes
- secondary myelodysplastic syndromes
- childhood myelodysplastic syndromes
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Oregon Cancer Institute | Portland, Oregon 97201-3098 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Genesis Medical Center | Davenport, Iowa 52804 |
