Leukemia Clinical Trial
Official title:
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:
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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