A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL

Study Overview
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Brief Summary
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The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.

Official Title
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A Phase II Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL

Conditions
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Vincristine Induced Neuropathy

Intervention / Treatment
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* Drug: Acetylcarnitine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet the following inclusion criteria. The subject must have a confirmed diagnosis of acute lymphoblastic leukemia within 1 week of starting therapy Currently being treated on a standard ALL induction regimen Subjects must be greater than or equal to 5 and less than 18 years old Signed informed consent Exclusion Criteria: Subjects will be excluded for the following: Preexisting neurologic disease, including grade II, III, or IV neurological status by NCI Common Toxicity Criteria v3.0 on clinical exam History of hypersensitivity to vincristine History of hypersensitivity to Acetyl-L-carnitine Previous use of Acetyl-L-carnitine Concurrent anti-convulsant use Concurrent Gabapentin use Concurrent Glutamine use Liver Function: Total bilirubin greater than 1.3 mg/dL and serum glutamic-pyruvic transaminase (SGPT) (ALT) greater than 5 x upper limit of normal for age and serum albumin less than 2 g/dL Patients who are pregnant

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyl-L-Carnitine only<br>The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done. | Drug: Acetylcarnitine<br>* Acetylcarnitine is taken 2 times a day for days 1 through 21.<br>|
| Experimental: Acetyl-L-Carnitine or Placebo<br>Subjects 16-30 will be randomized to receive drug or placebo. | Drug: Acetylcarnitine<br>* Acetylcarnitine is taken 2 times a day for days 1 through 21.<br>Drug: Placebo<br>* Placebo is taken 2 times a day for days 1 through 21.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score. |  | Days 1 - 21 |