Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
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.
Biological: anti-thymocyte globulin
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept|
- Response rate [ Designated as safety issue: No ]
- Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses [ Designated as safety issue: No ]
- Identify parameters that are associated with a high probability of response [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217386
|United States, Washington|
|St. Joseph Cancer Center|
|Bellingham, Washington, United States, 98225-1898|
|Olympic Medical Center|
|Port Angeles, Washington, United States, 98362|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Bart L. Scott, MD||Fred Hutchinson Cancer Research Center|