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S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00016419
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Biological: anti-thymocyte globulin Drug: cyclosporine Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)
Study Start Date : August 2001
Actual Primary Completion Date : July 2003
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Biological: anti-thymocyte globulin
    3.5 mg/kg/d IV over 12 hrs day 1
  • Drug: cyclosporine
    3 mg/kg bid days 5-94 then taper to 0 at day 124 PO

Outcome Measures
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Primary Outcome Measures :
  1. total response [ Time Frame: after induction therapy is completed ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016419


  Show 94 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Charles A. Schiffer, MD Barbara Ann Karmanos Cancer Institute
More Information
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00016419     History of Changes
Other Study ID Numbers: S0020
S0020 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Southwest Oncology Group:
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
 de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Cyclosporins
Cyclosporine
 Antilymphocyte Serum
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors