Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol
Patients with ALL on Total XVI who experience NP/PN after specific doses of vincristine are
eligible to enroll in the study as soon as the diagnosis of NP/PN related to VCR is
established. The qualifying doses of vincristine have been selected because they fall in the
schedule of weekly vincristine doses as per Total XVI, and 2 additional weekly vincristine
doses are anticipated according to the protocol. Participants will be randomized to receive
gabapentin or placebo upon enrollment. Morphine will be available to both groups as needed
for pain at any time on the study. At the time of enrollment, and daily thereafter until
completion of the study drug, data will be collected for pain assessment, and the daily dose
of oral morphine used will be collected. Data regarding the pain type, quality, and
location, as well as treatments used to manage pain will be assessed on a daily basis for
the diagnostic event and for the period following the next two administrations of VCR
treated with the study drug.
Primary Objective: To assess the analgesic efficacy of gabapentin in controlling
VCR-related NP/PN in participants with ALL, by comparing the morphine daily dose (mg/kg/day)
used to control NP/PN as a primary or a rescue regimen in the gabapentin vs. placebo groups.
Secondary Objective: To compare the pain scores in the gabapentin and placebo groups as
recorded by pain score right now and pain score average for previous 24 hours.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Daily total dose of oral morphine (mg/kg/day).
A quantity measured by pill count and/or adherence interview
Daily beginning day 1 for a maximum of 21 days.
Doralina Anghelescu, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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