A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
This study is ongoing, but not recruiting participants.
Sponsor:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01463852
First received: October 31, 2011
Last updated: March 8, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia (CLL) |
Drug: vincristine |
Phase 0 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 14 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vincrisitne 2mg
Single Arm study: Vincristine 2mg administered IV by infusion over 5 minutes.
|
Drug: vincristine
Vincristine 2mg will be administered one time to participants. Blood samples will be collected pre and post dose.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, 18 years old or older.
- A diagnosis of Chronic Lymphocytic Leukemia(CLL) which is CD5/CD19/CD23 positive, confirmed by peripheral blood immunophenotyping and/or lymph node biopsy and immunophenotyping and/or bone marrow biopsy and immunophenotyping. CD23-negative CLL cases are eligible, however additional diagnostic confirmation should include absence of Cyclin D1 rearrangement [t(11;14)] as determined by standard laboratory methods (such as fluorescent in situ hybridization).
- Patients are planning to start chemotherapy for CLL recommended and prescribed by their primary oncologist.
- Peripheral blood lymphocyte count above 20,000/mm3
- Be able to provide written informed consent
Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vincristine.
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Liver function test abnormalities of ≥ grade 3 (total bilirubin >3 ULN (upper limit of normal), AST> 5 ULN, ALT> 5 ULN) as per CTCAE 4.0 criteria, or direct bilirubin ≥ 3.0 mg/dL
- Pre-existing neuropathy grade 2 or greater as per CTCAE 4.0 criteria (moderate symptoms limiting instrumental activities of daily living - ADLs)
- Patients who are pregnant or planning to become pregnant during their participation in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463852
Locations
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
| Principal Investigator: | Alexey V Danilov, MD | Dartmouth-Hitchcock Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT01463852 History of Changes |
| Other Study ID Numbers: | D11199 |
| Study First Received: | October 31, 2011 |
| Last Updated: | March 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
vincristine JNK phosphorylation |
cll vinca alkaloid apoptosis |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Vinca Alkaloids Vincristine Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 13, 2013