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

NCT02598622 | Terminated Phase 2 Results DMC

• 1 other identifier: 1011003177
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vincristine Induced Neuropathy

Outcome Measures

Primary Outcomes (1)

• Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.

  Days 1 - 21

Study Arms (2)

Acetyl-L-Carnitine only

EXPERIMENTAL

The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.

Drug: Acetylcarnitine

Acetyl-L-Carnitine or Placebo

EXPERIMENTAL

Subjects 16-30 will be randomized to receive drug or placebo.

Drug: Acetylcarnitine; Drug: Placebo

Interventions

Acetylcarnitine DRUG

Acetylcarnitine is taken 2 times a day for days 1 through 21.

Acetyl-L-Carnitine only; Acetyl-L-Carnitine or Placebo

Placebo DRUG

Placebo is taken 2 times a day for days 1 through 21.

Acetyl-L-Carnitine or Placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Interventions

Acetylcarnitine

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Unable to meet enrollment goals. Drug expired prior to being able to enroll total subjects.

Results Point of Contact

• Title: Dr. Chie Schin-Shih
• Organization: Indiana University

shih2@iu.edu

317-944-8784

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: November 6, 2015
• Study Start: September 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2016
• Last Updated: March 3, 2017
• Results First Posted: April 28, 2016

Record last verified: 2017-02