Biological Therapy in Treating Patients With Myelodysplastic Syndrome
NCT ID: NCT00005853
Last Updated: 2010-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-12-31
2005-08-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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anti-thymocyte globulin
etanercept
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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H. Joachim Deeg, MD
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1478.00
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1793
Identifier Type: -
Identifier Source: secondary_id
CDR0000067878
Identifier Type: REGISTRY
Identifier Source: secondary_id
1478.00
Identifier Type: -
Identifier Source: org_study_id
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