Investigating the Temporal Relationship Vincristine Induced Peripheral Neuropathy in Children and Adolescents with Cancer

J
Jenny Belsky, DO

Primary Investigator

Enrolling By Invitation
10 years - 20 years
All
Phase N/A
60 participants needed
1 Location

Brief description of study

What is the purpose of this study?
2.1 Primary Objective
Identify early axonal damage patterns, and correlate findings with genes, biomarkers, and existing clinically validated clinician neuropathic reporting tools.
2.2 Secondary Objectives
Characterize the longitudinal pattern of axonal damage in CAYAs with cancer receiving VCR.
Investigate the correlation between novel biomarkers of axonal damage and changes in clinical neuropathic grading.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
Eligible patients will be identified at weekly disease team meetings by a research team member, or by the inpatient oncology physician. Patients deemed eligible will be approached at diagnosis by a study team member to obtain consent (age ≥18-21) or assent (patients aged ≥10-17) from interested patients. Patient age was chosen due to established cuff-off values of Nfl, including a recent large cohort providing normative values, and to focus on high risk ALL patients (age ≥10 years). Patients must enroll within 5 days of receiving their first dose of VCR. Participants will be followed with NCS and Nfl from peripheral blood, and clinician grading at 3 timepoints. CEP72 will be obtained at baseline, following clearance of peripheral blasts. Time Point (TP) 1 will occur at baseline for all patients. TP 2 is dependent on patient protocol and will occur at 50% planned VCR exposure (for ALL interim maintenance 1, Lymphoma cycle 3, RMS week 22), TP 3 will correlate with maximum VCR exposure at end of therapy for lymphoma and RMS, and the start of maintenance for patients with leukemia correlating with maximum VCR exposure in all groups. Blood draws and CTCAE grading will occur during routine visits by the clinical research nurse (CRN) and timed with existing laboratory orders and port access. Participants have routine blood draws as part of standard clinical care at each chemotherapy visit by our CRN. CEP72 and Nfl via blood draw will be collected by existing central line or venipuncture while labs are otherwise obtained for clinical purposes.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: B-acute lymphoblastic leukemia (ALL), lymphoma, rhabdomyosarcoma, cancer, Riley
  • Age: 10 years - 20 years
  • Gender: All

Inclusion Criteria
1.    ≥ 10 to < 21 years old at the time of enrollment
2.    Ability to provide written informed consent/assent and HIPAA authorization
3.    An oncology diagnosis of B-acute lymphoblastic leukemia (ALL), lymphoma, or rhabdomyosarcoma planning to receive VCR
4.    Plan to receive the entirety of their care at Riley Hospital for Children

Exclusion Criteria
•    Patients with relapsed or secondary cancers will be excluded from the study due to confounding baseline variables
•    Patients with pre-existing neurologic conditions, mass compressing the median motor, median sensory, peroneal motor, or sural nerves will be excluded due to confounding baseline variables
•    Patients with an implanted electrical device (e.g. pacemakers) will be excluded do to interference with nerve conductions studies (NCS)

Updated on 21 Apr 2025. Study ID: PHO-IIR-IUSCCC-0873, 22729
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