Myelodysplastic Syndrome Clinical Trial
Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes
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 interfere with the growth of the cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide together with etanercept and to see how well it works in treating patients with myelodysplastic syndromes.
Full 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 the efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872.
Correlate results of ex vivo and in vitro studies of phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment response in patients treated with this regimen.
Determine parameters that are associated with a high probability of disease response in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 of week 1 and then twice weekly on weeks 2-12 during course 1 (twice weekly on weeks 1-12 during course 2). Patients also receive etanercept subcutaneously twice weekly during weeks 1, 2, 5, 6, 9, and 10. Treatment repeats every 12 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18 months.
Eligibility Criteria
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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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