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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
30
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
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
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