A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | October 2012 |
| End Date: | December 2014 |
| Contact: | Alexey V Danilov, MD |
| Email: | cancer.research.nurse@Dartmouth.edu |
| Phone: | 603-650-9474 |
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation Status 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.
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.
Inclusion Criteria:
1. Male or female, 18 years old or older.
2. 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).
3. Patients are planning to start chemotherapy for CLL recommended and prescribed by
their primary oncologist.
4. Peripheral blood lymphocyte count above 20,000/mm3
5. Be able to provide written informed consent
Exclusion Criteria
1. 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.
2. Patients who are receiving any other investigational agents.
3. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to vincristine.
4. 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.
5. 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
6. Pre-existing neuropathy grade 2 or greater as per CTCAE 4.0 criteria (moderate
symptoms limiting instrumental activities of daily living - ADLs)
7. Patients who are pregnant or planning to become pregnant during their participation
in the study.
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