A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia
NCT ID: NCT00559091
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2007-04-30
2010-02-28
Brief Summary
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Detailed Description
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While ribavirin has been used extensively for the treatment of viral hepatitis C and its safety profile has been well defined, it has never been used in patients with AML. This study will establish the efficacy and safety of ribavirin in M4/M5 AML patients. In addition, this study will also include correlative studies to determine the effect of ribavirin on eIF4E activity and eIF4E related pathways in M4/M5 AML patients.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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I
Ribavirin
ribavirin
Ribavirin will be administered orally, twice daily, in the morning and evening with food. The dose selected is 400 mg AM and 600 mg PM. Intrapatient dose escalations can also be performed in defined circumstances. The maximal dose administered will be 1000 mg AM and 1000 mg PM.
Interventions
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ribavirin
Ribavirin will be administered orally, twice daily, in the morning and evening with food. The dose selected is 400 mg AM and 600 mg PM. Intrapatient dose escalations can also be performed in defined circumstances. The maximal dose administered will be 1000 mg AM and 1000 mg PM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with AML who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. OR
* Patients with AML blast crisis from CML if they are not suitable candidates for intensive induction chemotherapy or have failed imatinib mesylate OR
* Patients with secondary AML after MDS if they are not suitable candidates for intensive induction chemotherapy.
* ECOG 0,1,2, or 3
* Life expectancy \> 12 weeks.
* Adequate renal and hepatic function
Exclusion Criteria
* Active cardiovascular disease as defined by NYHA class III-IV categorization.
* Intercurrent illness or medical condition precluding safe administration of ribavirin.
* Received any previous therapy within 28 days prior to study entry.Hydrea is permitted but must be stopped 7 days prior to starting study drug.
* Known infection with HIV.
18 Years
ALL
No
Sponsors
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The Leukemia and Lymphoma Society
OTHER
Jewish General Hospital
OTHER
Responsible Party
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Sarit Assouline
Associate Professor, Department of Oncology, McGill University
Principal Investigators
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Sarit Assouline, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Kathy Borden, PhD
Role: STUDY_DIRECTOR
Université de Montréal
Locations
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McMaster Hospital
Hamilton, Ontario, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Topisirovic I, Guzman ML, McConnell MJ, Licht JD, Culjkovic B, Neering SJ, Jordan CT, Borden KL. Aberrant eukaryotic translation initiation factor 4E-dependent mRNA transport impedes hematopoietic differentiation and contributes to leukemogenesis. Mol Cell Biol. 2003 Dec;23(24):8992-9002. doi: 10.1128/MCB.23.24.8992-9002.2003.
De Benedetti A, Harris AL. eIF4E expression in tumors: its possible role in progression of malignancies. Int J Biochem Cell Biol. 1999 Jan;31(1):59-72. doi: 10.1016/s1357-2725(98)00132-0.
Kentsis A, Topisirovic I, Culjkovic B, Shao L, Borden KL. Ribavirin suppresses eIF4E-mediated oncogenic transformation by physical mimicry of the 7-methyl guanosine mRNA cap. Proc Natl Acad Sci U S A. 2004 Dec 28;101(52):18105-10. doi: 10.1073/pnas.0406927102. Epub 2004 Dec 15.
Assouline S, Culjkovic B, Cocolakis E, Rousseau C, Beslu N, Amri A, Caplan S, Leber B, Roy DC, Miller WH Jr, Borden KL. Molecular targeting of the oncogene eIF4E in acute myeloid leukemia (AML): a proof-of-principle clinical trial with ribavirin. Blood. 2009 Jul 9;114(2):257-60. doi: 10.1182/blood-2009-02-205153. Epub 2009 May 11.
Related Links
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Click here for more information about the study.
Other Identifiers
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REC:06-112
Identifier Type: -
Identifier Source: secondary_id
CR0620KB
Identifier Type: -
Identifier Source: org_study_id