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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005853 |
Purpose
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.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes |
Drug: anti-thymocyte globulin Drug: etanercept |
Phase II |
| MedlinePlus related topics: | Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| ChemIDplus related topics: | Etanercept |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc |
| Study Start Date: | December 1999 |
OBJECTIVES:
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiation therapy:
Surgery:
Other:
Contacts and Locations| United States, Washington | |||||
| Fred Hutchinson Cancer Research Center | |||||
| Seattle, Washington, United States, 98109 | |||||
| Fred Hutchinson Cancer Research Center |
| National Cancer Institute (NCI) |
| Study Chair: | H. Joachim Deeg, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067878, FHCRC-1478.00, NCI-G00-1793 |
| First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005853 |
| Health Authority: | United States: Federal Government |
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