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Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol


Phase 2
1 Year
18 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Neuropathy, Neuropathic Pain

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Trial Information

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.


Inclusion Criteria:



- Participant is enrolled on Total XVI

- 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: 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 while on study drug (i.e. no known dosage reductions or
planned missed doses).

Participant is able and willing to take oral medications.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Daily total dose of oral morphine (mg/kg/day).

Outcome Description:

A quantity measured by pill count and/or adherence interview

Outcome Time Frame:

Daily beginning day 1 for a maximum of 21 days.

Safety Issue:

No

Principal Investigator

Doralina Anghelescu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

TINALL

NCT ID:

NCT01506453

Start Date:

January 2012

Completion Date:

January 2016

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Neuropathy
  • Neuropathic Pain
  • Acute Lymphoblastic Leukemia
  • Neuropathy
  • Neuropathic Pain
  • Vincristine
  • TOTAL XVI Protocol
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neuralgia
  • Peripheral Nervous System Diseases

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794