Myelodysplastic Syndrome Clinical Trial
Biological Therapy in Treating Patients With Myelodysplastic Syndrome
Summary
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.
Full 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 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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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