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Biological Therapy in Treating Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005853
  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 II

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Etanercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
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
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

Study ID Numbers: CDR0000067878, FHCRC-1478.00, NCI-G00-1793
Study First Received: June 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005853     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
TNFR-Fc fusion protein
Immunosuppressive Agents
Refractory Anemia
Antilymphocyte Serum
Leukemia
Preleukemia
Anemia, Refractory
Analgesics, Non-Narcotic
Neoplasm Metastasis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Anemia, Refractory, with Excess of Blasts
Antirheumatic Agents
Bone Marrow Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
TNFR-Fc fusion protein
Leukemia
Preleukemia
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Antilymphocyte Serum
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Bone Marrow Diseases
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009