Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
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:
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.
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:
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 intermediate-2- or high-risk MDS
No chronic myelomonocytic leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other