Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
NCT ID: NCT00217386
Last Updated: 2010-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.
Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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anti-thymocyte globulin
etanercept
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Bart L. Scott, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1872.00
Identifier Type: -
Identifier Source: secondary_id
CDR0000430702
Identifier Type: REGISTRY
Identifier Source: secondary_id
1872.00
Identifier Type: -
Identifier Source: org_study_id