Clinical Trial: Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
Brief Summary:
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 Summary:
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.
Sponsor: Fred Hutchinson Cancer Research Center
Current Primary Outcome:
- 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
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fred Hutchinson Cancer Research Center
Dates:
Date Received: September 20, 2005
Date Started: March 2004
Date Completion:
Last Updated: September 13, 2010
Last Verified: September 2010