Biological Therapy in Treating Patients With Myelodysplastic Syndrome
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.
|Leukemia Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Biological: etanercept||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc|
|Study Start Date:||December 1999|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
- Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
- Determine the safety of this treatment regimen in this patient population.
OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.
Patients are followed at 8, 16, and 20 weeks.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005853
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||H. Joachim Deeg, MD||Fred Hutchinson Cancer Research Center|