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

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.

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