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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005853 |
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 |
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Leukemia Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Biological: etanercept |
Phase II |
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.
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:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | H. Joachim Deeg, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067878, FHCRC-1478.00, NCI-G00-1793 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005853 History of Changes |
Health Authority: | United States: Federal Government |
refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation de novo myelodysplastic syndromes |
previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory cytopenia with multilineage dysplasia childhood myelodysplastic syndromes |
Anti-Inflammatory Agents Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Anemia TNFR-Fc fusion protein Immunosuppressive Agents Refractory Anemia Antilymphocyte Serum Leukemia |
Preleukemia Anemia, Refractory Analgesics, Non-Narcotic Neoplasm Metastasis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Anemia, Refractory, with Excess of Blasts Antirheumatic Agents Bone Marrow Diseases |
Anti-Inflammatory Agents Precancerous Conditions Immunologic Factors Physiological Effects of Drugs TNFR-Fc fusion protein Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Disease |
Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Bone Marrow Diseases Antirheumatic Agents Central Nervous System Agents |