Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
18 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
Safety Issue:
No
Principal Investigator
Bart L. Scott, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1888.00
NCT ID:
NCT00093366
Start Date:
June 2004
Completion Date:
July 2006
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative disease, unclassifiable
- atypical chronic myeloid leukemia
- chronic myelomonocytic leukemia
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
