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

Phase 2

Terminated

• Conditions: Vincristine Induced Neuropathy
• Interventions: Drug: Acetylcarnitine; Drug: Placebo

• Registration Number: NCT02598622
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-05
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Study Completion: 2016-01
• Results First Submitted: 2016-02-22
• Results First Submitted QC: 2016-03-28
• Results First Posted: 2016-04-28
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetyl-L-Carnitine only	Acetylcarnitine	The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetyl-L-Carnitine or Placebo	Acetylcarnitine	Subjects 16-30 will be randomized to receive drug or placebo.
Acetyl-L-Carnitine or Placebo	Placebo	Subjects 16-30 will be randomized to receive drug or placebo.

Primary Outcome Measures

Name	Time	Method
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.	Days 1 - 21