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

NCT ID: NCT02598622

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Acetyl-L-Carnitine only

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

Group Type: EXPERIMENTAL

Acetylcarnitine

Intervention Type: DRUG

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

Acetyl-L-Carnitine or Placebo

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

Group Type: EXPERIMENTAL

Acetylcarnitine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

Acetylcarnitine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Chie-Schin Shih

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1011003177

Identifier Type: -

Identifier Source: org_study_id