Biological Therapy in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00005853
First received: June 2, 2000
Last updated: March 31, 2010
Last verified: March 2010

June 2, 2000
March 31, 2010
December 1999
August 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005853 on ClinicalTrials.gov Archive Site
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Biological Therapy in Treating Patients With Myelodysplastic Syndrome
Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.

OBJECTIVES:

  • Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
  • Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
  • Determine the safety of this treatment regimen in this patient population.

OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.

Patients are followed at 8, 16, and 20 weeks.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Interventional
Phase 2
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Biological: anti-thymocyte globulin
  • Biological: etanercept
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005
August 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:

    • Single or multilineage cytopenia (neutrophils less than 2,000/mm^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) OR
    • Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:

      • Suitable marrow donor unavailable
      • Ineligible for a transplantation protocol
      • Unwilling to proceed with transplantation
  • No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other severe disease that would preclude study
  • No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior hematopoietic growth factors
  • No concurrent hematopoietic growth factors

Chemotherapy:

  • At least 4 weeks since prior cytotoxic therapy
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiation therapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior immunomodulatory therapy
  • No concurrent immunomodulatory therapy
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005853
1478.00, FHCRC-1478.00, NCI-G00-1793, CDR0000067878
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: H. Joachim Deeg, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP