Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

Conditions
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Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Intervention / Treatment
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* Biological: anti-thymocyte globulin
* Biological: etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: anti-thymocyte globulin|nan|
|Biological: etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses |  |  | 
| Identify parameters that are associated with a high probability of response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, atypical chronic myeloid leukemia