- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00093366
Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes
Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
|
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 on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
|
Parameters that are associated with a high probability of response
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bart L. Scott, MD, Fred Hutchinson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Sykdom
- Benmargssykdommer
- Hematologiske sykdommer
- Forstadier til kreft
- Syndrom
- Myelodysplastiske syndromer
- Leukemi
- Preleukemi
- Myeloproliferative lidelser
- Myelodysplastiske-myeloproliferative sykdommer
- Fysiologiske effekter av legemidler
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Etanercept
- Arsen trioksid
Andre studie-ID-numre
- 1888.00
- FHCRC-1888.00
- CDR0000380742 (Registeridentifikator: PDQ)
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