A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia

NCT00559091 | Completed Phase 2

• 2 other identifiers: CR0620KBREC:06-112
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if ribavirin (a drug commonly used to treat hepatitis C) also has activity in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML) of the M4 and M5 subtype.

Conditions

Acute Myelocytic Leukemia

Keywords

AML; Acute myelocytic leukemia; leukemia; relapsed; refractory; M4; M5

Outcome Measures

Primary Outcomes (1)

• Measure: Overall response rate

  6 months

Secondary Outcomes (1)

• Measure: Safety and tolerability, correlative studies

  6 months

Study Arms (1)

I

EXPERIMENTAL

Ribavirin

Drug: ribavirin

Interventions

ribavirin DRUG

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.

Also known as: Ribasphere (Three Rivers Pharmaceuticals)

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of acute myeloid leukemia (AML), either M4 or M5 subtype de novo or resulting from a transformation from MDS or a myeloproliferative disorder.
• 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

You may not qualify if:

• Uncontrolled central nervous system involvement by AML
• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (3)

McMaster Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H4T 1E2, Canada

Location

Related Publications (4)

• 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.

  PMID: 14645512 BACKGROUND

• 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.

  PMID: 10216944 BACKGROUND

• 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.

  PMID: 15601771 BACKGROUND

• 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.

  PMID: 19433856 BACKGROUND

Related Links

• Click here for more information about the study.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia; Recurrence

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sarit Assouline, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Kathy Borden, PhD

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Oncology, McGill University

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CA (3)