Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

Conditions
-----------------
Leukemia, Myelodysplastic Syndromes

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


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes