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

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Acetylcarnitine; Vincristine

Criteria

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