anti-thymocyte globulin and etanercept in treating patients with myelodysplastic syndromes

Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Summary: rationale: biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. giving anti-thymocyte globulin together with etanercept may kill more cancer cells. purpose: this phase ii trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

objectives: * determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept. * correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease characteristics with in vivo response in patients treated with this regimen. * determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen. outline: this is a multicenter study. patients receive anti-thymocyte globulin iv over 8 hours on days 1-4. patients also receive etanercept subcutaneously on days 8, 11, 15, and 18. treatment with etanercept repeats every 28 days for at least 2 courses. patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity. patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment. after completion of study treatment, patients are followed periodically. projected accrual: a total of 30 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of myelodysplastic syndromes (mds) * low- or intermediate-1-risk disease, as defined by international prognostic scoring system (ipss) criteria, meeting 1 of the following criteria: * single or multilineage cytopenia, as defined by all of the following: * absolute neutrophil count \< 1,500/mm\^3 * hemoglobin \< 10 g/dl * platelet count \< 100,000/mm\^3 * transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period * not eligible for stem cell transplantation due to any of the following reasons: * no suitable bone marrow donor available * not eligible for a transplantation protocol * not willing to undergo transplantation * no intermediate-2- or high-risk mds * no chronic myelomonocytic leukemia patient characteristics: age * 18 and over performance status * not specified life expectancy * not specified hematopoietic * see disease characteristics hepatic * not specified renal * not specified pulmonary * no pneumonia within the past 2 weeks other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other severe disease that would preclude study compliance * no other active severe infection (e.g., septicemia) within the past 2 weeks prior concurrent therapy: biologic therapy * more than 4 weeks since prior and no concurrent hematopoietic growth factors for mds * more than 4 weeks since prior immunomodulatory therapy for mds * no prior anti-thymocyte globulin * no prior hematopoietic stem cell transplantation * no other concurrent immunomodulatory therapy for mds chemotherapy * not specified endocrine therapy * prednisone \< 5 mg/day allowed radiotherapy * not specified surgery * not specified other * more than 4 weeks since prior and no concurrent cytotoxic therapy for mds * more than 4 weeks since prior experimental therapy for mds * no other concurrent experimental therapy for mds

Keywords: de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable atypical chronic myeloid leukemia