Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Biological: etanercept |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2004 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes (MDS)
Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria:
Single or multilineage cytopenia, as defined by all of the following:
- Absolute neutrophil count < 1,500/mm^3
- Hemoglobin < 10 g/dL
- Platelet count < 100,000/mm^3
- Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period
Not eligible for stem cell transplantation due to any of the following reasons:
- No suitable bone marrow donor available
- Not eligible for a transplantation protocol
- Not willing to undergo transplantation
- No intermediate-2- or high-risk MDS
- No chronic myelomonocytic leukemia
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
- No pneumonia within the past 2 weeks
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other severe disease that would preclude study compliance
- No other active severe infection (e.g., septicemia) within the past 2 weeks
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS
- More than 4 weeks since prior immunomodulatory therapy for MDS
- No prior anti-thymocyte globulin
- No prior hematopoietic stem cell transplantation
- No other concurrent immunomodulatory therapy for MDS
Chemotherapy
- Not specified
Endocrine therapy
- Prednisone < 5 mg/day allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS
- More than 4 weeks since prior experimental therapy for MDS
- No other concurrent experimental therapy for MDS
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bart L. Scott, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00217386 History of Changes |
| Other Study ID Numbers: | 1872.00, FHCRC-1872.00, CDR0000430702 |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable atypical chronic myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases 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 18, 2013