Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Fred Hutchinson Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Leukemia Myelodysplastic Syndromes

Interventions

anti-thymocyte globulinBIOLOGICAL

etanerceptBIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Data from ClinicalTrials.gov

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