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
  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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Biological: anti-thymocyte globulin
Biological: etanercept
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: December 1999
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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
Accepts Healthy Volunteers:   No
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^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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005853

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: H. Joachim Deeg, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005853     History of Changes
Other Study ID Numbers: 1478.00, FHCRC-1478.00, NCI-G00-1793, CDR0000067878
Study First Received: June 2, 2000
Last Updated: March 31, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory cytopenia with multilineage dysplasia
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Antilymphocyte Serum
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014