Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
Intervention: azacitidine (Drug); etanercept (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Fred Hutchinson Cancer Research Center
Official(s) and/or principal investigator(s):
Bart L. Scott, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Biological therapies, such as etanercept, may interfere with the growth of cancer cells.
Giving azacitidine together with etanercept may kill more cancer cells.
PURPOSE: This phase I/II trial is studying how well giving azacitidine together with
etanercept works in treating patients with myelodysplastic syndromes.
Official title: Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study
Study design: Treatment, Open Label
Hematologic response in patients with intermediate-2- or high-risk myelodysplastic syndromes (MDS) treated with azacitidine and etanercept
Efficacy of this regimen in patients with intermediate-1- or low-risk MDS that failed prior anti-thymocyte globulin and etanercept on protocol FHCRC-1872.00
Correlate results of ex vivo and in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
Parameters that are associated with a high probability of response
- Determine the frequency of hematologic response in patients with intermediate-2- or
high-risk myelodysplastic syndromes (MDS) treated with azacitidine and etanercept.
- Determine the efficacy of this regimen in patients with intermediate-1- or low-risk MDS
that failed prior anti-thymocyte globulin and etanercept on protocol FHCRC-1872. 00.
- Correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease
characteristics with in vivo response in patients treated with this regimen.
- Determine parameters associated with a high probability of response in patients treated
with this regimen.
OUTLINE: This is a multicenter study.
Patients receive azacitidine subcutaneously (SC) on days 1-7. Patients also receive
etanercept SC on days 8, 11, 15, and 18. Treatment repeats every 28 days for at least 3
courses. Patients with a complete or partial response, evidence of hematologic improvement,
or stable disease after 3 courses continue to receive study therapy in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Minimum age: 18 Years.
Maximum age: N/A.
- Diagnosis of myelodysplastic syndromes (MDS), meeting 1 of the following criteria:
- Intermediate-2- or high-risk disease
- Intermediate-1- or low-risk disease AND failed* prior therapy with anti-thymocyte
globulin and etanercept on protocol FHCRC-1872. 00 NOTE: *Failure is defined as
progression or "more advanced" disease
- Not a candidate 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
- Not eligible for enrollment on protocol FHCRC-1888. 00
- No acute myeloid leukemia (i. e., ≥ 20% blasts)
- 18 and over
- ECOG 0-2
- Not specified
- Absolute neutrophil count > 250/mm^3
- Platelet count > 100,000/mm^3
- AST and ALT ≤ 2 times upper limit of normal (ULN)
- Creatinine ≤ 1. 5 times ULN
- No history of or current evidence of cardiac arrhythmia
- No history of or current evidence of congestive heart failure
- No pneumonia within the past 2 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active severe infection (e. g., septicemia or pneumonia) within the past 2
- No other severe disease that would preclude study compliance
- No known or suspected hypersensitivity to azacitidine or mannitol
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
- 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 other concurrent immunomodulatory therapy for MDS
- No prior azacitidine
- Not specified
- Not specified
- Not specified
- More than 2 weeks since prior cytotoxic therapy for MDS
- More than 2 weeks since prior experimental therapy for MDS
- No other concurrent cytotoxic therapy for MDS
- No other concurrent experimental therapy for MDS
Locations and Contacts
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States
Seattle Cancer Care Alliance, Seattle, Washington 98109-1023, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2005
Last updated: May 29, 2008