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

February 28, 2017 updated by: Chie-Schin Shih, Indiana University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1011003177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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