A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia (Borden-001)
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.
|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|
- Measure: Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Measure: Safety and tolerability, correlative studies [ Time Frame: 6 months ]
|Study Start Date:||April 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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)
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.
|Hamilton, Ontario, Canada, L8N 3Z5|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H4T 1E2|
|Montreal, Quebec, Canada, H1T 2M4|
|Principal Investigator:||Sarit Assouline, MD||Jewish General Hospital|
|Study Director:||Kathy Borden, PhD||Université de Montréal|