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


Phase 2
15 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

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