Status:
COMPLETED
Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as etanercept may inte...
Detailed Description
OBJECTIVES: * Determine the frequency of hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) treated with arsenic trioxide and etanercept. * Determine th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
- Intermediate-2 or high-risk disease
- Intermediate-1 or low-risk disease that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872
- Not eligible for stem cell transplantation for any of the following reasons:
- Suitable bone marrow donor is not available
- Ineligible for a transplantation protocol
- Not willing to undergo transplantation
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 500/mm\^3
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- No evidence of cardiac arrhythmia
- No evidence of congestive heart failure
- QTc interval ≤ 460 msec
- Pulmonary
- No pneumonia
- Other
- Potassium \> 4.0 mEq/L (supplemental electrolytes allowed)
- Magnesium \> 1.8 mg/dL (supplemental electrolytes allowed)
- No history of anaphylactic reaction to arsenic trioxide
- No active severe infection (e.g., septicemia) within the past 2 weeks
- No other severe disease that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
- More than 4 weeks since prior hematopoietic growth factors for MDS
- More than 4 weeks since prior immunomodulatory therapy for MDS
- No concurrent hematopoietic growth factors for MDS
- No other concurrent immunomodulatory therapy for MDS
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- More than 4 weeks since prior cytotoxic therapy for MDS
- More than 4 weeks since prior experimental therapy for MDS
- No other concurrent cytotoxic therapy for MDS
- No other concurrent experimental therapy for MDS
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00093366
Start Date
June 1 2004
End Date
July 1 2006
Last Update
November 30 2011
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024