Biological Therapy in Treating Patients With Myelodysplastic Syndrome
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00005853
First received: June 2, 2000
Last updated: March 31, 2010
Last verified: March 2010
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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 |
Biological: anti-thymocyte globulin Biological: etanercept |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc |
Resource links provided by NLM:
Further study details as provided by Fred Hutchinson Cancer Research Center:
| Study Start Date: | December 1999 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
- Single or multilineage cytopenia (neutrophils less than 2,000/mm^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) OR
Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:
- Suitable marrow donor unavailable
- Ineligible for a transplantation protocol
- Unwilling to proceed with transplantation
- No chronic myelomonocytic leukemia
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other severe disease that would preclude study
- No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior hematopoietic growth factors
- No concurrent hematopoietic growth factors
Chemotherapy:
- At least 4 weeks since prior cytotoxic therapy
- No concurrent cytotoxic therapy
Endocrine therapy:
- Not specified
Radiation therapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 4 weeks since prior immunomodulatory therapy
- No concurrent immunomodulatory therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005853
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Study Chair: | H. Joachim Deeg, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005853 History of Changes |
| Other Study ID Numbers: | 1478.00, FHCRC-1478.00, NCI-G00-1793, CDR0000067878 |
| Study First Received: | June 2, 2000 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
Leukemia Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Antilymphocyte Serum TNFR-Fc fusion protein Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013