Status:
COMPLETED
Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Lymphoblastic Leukemia
Neuropathy
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin...
Detailed Description
Patients with ALL on Total XVI ((or for those being treated "as per TOTXVI protocol") who experience NP/PN after specific doses of vincristine are eligible to enroll in the study as soon as the diagno...
Eligibility Criteria
Inclusion
- Participant is enrolled on Total XVI or who are being treated "as per TOTXVI protocol"
- Participant is 1 year of age or older
- Participant has symptoms of NP/PN with onset no more than 7 days after one of the following vincristine doses ± 3 days: protocol week 1, week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II).
- Patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the Total XVI protocol (or for those being treated "as per TOTXVI" protocol) while on study drug (i.e. no known dosage reductions or planned missed doses).
- Participant is able and willing to take oral medications.
Exclusion
- Previous participation in this study
- Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously.
- Pregnancy. Female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. Male patients with reproductive potential will be counseled not to procreate during the study.
- Impaired renal function: decreased eGFR (\<60ml/min/1.73m\^2 as estimated by the revised Schwartz equation)
- Participant has allergy or other contraindication for either morphine or gabapentin therapy.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Key Trial Info
Start Date :
January 24 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01506453
Start Date
January 24 2012
End Date
January 2 2018
Last Update
June 19 2019
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105