Expired Study
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Seattle, Washington 98109


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.


Study summary:

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.


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


NCT ID:

NCT00005853


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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