A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia (Borden-001)
This study has been completed.
Sponsor:
Jewish General Hospital
Collaborator:
The Leukemia and Lymphoma Society
Information provided by:
Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT00559091
First received: November 15, 2007
Last updated: May 6, 2011
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelocytic Leukemia |
Drug: ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Ribavirin in Refractory of Relapsed Acute Myelocytic Leukemia M4 and M5 Subtypes |
Resource links provided by NLM:
Further study details as provided by Jewish General Hospital:
Primary Outcome Measures:
- Measure: Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure: Safety and tolerability, correlative studies [ Time Frame: 6 months ]
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
Ribavirin
|
Drug: 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 Name: Ribasphere (Three Rivers Pharmaceuticals)
|
Detailed Description:
The eukaryotic translation initiation factor eIF4E is dysregulated in many human malignancies, including a subset of myeloid leukemia (M4/M5 AML and blast crisis CML). eIF4E overexpression leads to oncogenic transformation. Ribavirin impedes eIF4E mediated transformation in vitro, in primary human specimens and in animal models.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559091
Locations
| Canada, Ontario | |
| McMaster Hospital | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada, H4T 1E2 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
Sponsors and Collaborators
Jewish General Hospital
The Leukemia and Lymphoma Society
Investigators
| Principal Investigator: | Sarit Assouline, MD | Jewish General Hospital |
| Study Director: | Kathy Borden, PhD | Université de Montréal |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Sarit Assouline / Associate Director, Clinical Research Unit, Jewish General Hospital, McGill University |
| ClinicalTrials.gov Identifier: | NCT00559091 History of Changes |
| Other Study ID Numbers: | CR0620KB, REC:06-112 |
| Study First Received: | November 15, 2007 |
| Last Updated: | May 6, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Jewish General Hospital:
|
AML Acute myelocytic leukemia leukemia relapsed |
refractory M4 M5 |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Ribavirin |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013