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Status:

COMPLETED

Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

Lead Sponsor:

Fred Hutchinson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin to...

Detailed Description

OBJECTIVES: * Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept. * Correlate ex vivo and in vitro ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of myelodysplastic syndromes (MDS)
  • Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria:
  • Single or multilineage cytopenia, as defined by all of the following:
  • Absolute neutrophil count \< 1,500/mm\^3
  • Hemoglobin \< 10 g/dL
  • Platelet count \< 100,000/mm\^3
  • Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period
  • Not eligible for stem cell transplantation due to any of the following reasons:
  • No suitable bone marrow donor available
  • Not eligible for a transplantation protocol
  • Not willing to undergo transplantation
  • No intermediate-2- or high-risk MDS
  • No chronic myelomonocytic leukemia
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Not specified
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Pulmonary
  • No pneumonia within the past 2 weeks
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe disease that would preclude study compliance
  • No other active severe infection (e.g., septicemia) within the past 2 weeks
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS
  • More than 4 weeks since prior immunomodulatory therapy for MDS
  • No prior anti-thymocyte globulin
  • No prior hematopoietic stem cell transplantation
  • No other concurrent immunomodulatory therapy for MDS
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Prednisone \< 5 mg/day allowed
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS
  • More than 4 weeks since prior experimental therapy for MDS
  • No other concurrent experimental therapy for MDS

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00217386

    Start Date

    March 1 2004

    Last Update

    September 15 2010

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    St. Joseph Cancer Center

    Bellingham, Washington, United States, 98225-1898

    2

    Olympic Medical Center

    Port Angeles, Washington, United States, 98362

    3

    Seattle Cancer Care Alliance

    Seattle, Washington, United States, 98109-1023

    4

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024