A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this single dose will induce rapid cell death in isolated CLL cells.
Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood samples will be collected from an intravenous line inserted into the contralateral limb to that where the vincristine was given, at time zero (pre-vincristine treatment), immediately after vincristine administration (within 2-10 minutes upon completion of administration) and at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive chemotherapy treatment as prescribed by their primary oncologist.
Within 7 days of vincristine administration, participants will receive a phone call from the research nurse to discuss potential toxicities. At the time of the initiation of standard chemotherapy treatment, the Principal Investigator will also meet with the participant to collect information regarding adverse events.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation Status in Patients With Chronic Lymphocytic Leukemia (CLL)|
- c-Jun N-terminal Kinase (JNK) activation [ Time Frame: Change in JNK activation from baseline up to 6 hours post dose ] [ Designated as safety issue: No ]blood draws are collected pre-vincristine and at 10 minutes,1,2,4,and 6 hours post vincristine.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Vincrisitne 2mg
Single Arm study: Vincristine 2mg administered IV by infusion over 5 minutes.
Vincristine 2mg will be administered one time to participants. Blood samples will be collected pre and post dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463852
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Alexey V Danilov, MD||Dartmouth-Hitchcock Medical Center|