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Biological Therapy in Treating Patients With Myelodysplastic Syndrome - Article


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Immune Globulin Intravenous Injection

Gamimune N; Gammagard S/D; Gammar-IV; Gammar-P I.V.; IGIV; Iveegam; Panglobulin; Polygam S/D; Sandoglobulin; Venoglobulin-S


Clinical Trial: Biological Therapy in Treating Patients With Myelodysplastic Syndrome

This study is no longer recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
Myelodysplastic Syndromes
 Drug: anti-thymocyte globulin
 Drug: tumor necrosis factor receptor IgG chimera
 Procedure: anti-cytokine therapy
 Procedure: anti-tumor necrosis factor therapy
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
Phase II

MedlinePlus related topics:  Bone Marrow Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Anti-Thymocyte Globulin and Tumor Necrosis Factor Receptor IgG Chimera in Patients With Myelodysplastic Syndrome

Further Study Details: 

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.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
  • Single or multilineage cytopenia (neutrophils less than 2,000/mm
  • and/or platelet count less than 100,000/mm
  • and/or reticulocyte count less than 18,000/mm
  • ) 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:

Endocrine therapy:

  • Not specified

Radiation therapy:

  • Not specified

Surgery:

  • Not specified

Other:

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

Location Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

H. Joachim Deeg, MD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067878; FHCRC-1478.00; NCI-G00-1793
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005853
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 11, 2008



Page Updated: June 1, 2005
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