- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00217386
Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Washington
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Bellingham, Washington, United States, 98225-1898
- St. Joseph Cancer Center
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Port Angeles, Washington, United States, 98362
- Olympic Medical Center
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Seattle, Washington, United States, 98109-1023
- Seattle Cancer Care Alliance
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate
|
Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
|
Identify parameters that are associated with a high probability of response
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bart L. Scott, MD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
- Antilymphocyte Serum
Other Study ID Numbers
- 1872.00
- FHCRC-1872.00
- CDR0000430702 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myelodysplastic Syndromes
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndromes | Secondary Myelodysplastic Syndromes | de Novo Myelodysplastic SyndromesUnited States
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National Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndromes | Secondary Myelodysplastic Syndromes | de Novo Myelodysplastic SyndromesUnited States
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GCP-Service International West GmbHSaint-Louis Hospital, Paris, France; University of Florence; Medical University... and other collaboratorsNot yet recruitingLow Risk Myelodysplastic SyndromesSpain, Poland, Italy, Germany, France
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I-Mab Biopharma Co. Ltd.Recruiting
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The First Affiliated Hospital with Nanjing Medical...UnknownMyelodysplastic Syndromes (MDS)China
-
Sumitomo Pharma America, Inc.TerminatedMyelodysplastic Syndromes (MDS)United States
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