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

Indiana University

Status and phase: Terminated; Phase 2

Conditions: Vincristine Induced Neuropathy

Treatments: Drug: Acetylcarnitine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02598622

1011003177

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Acetyl-L-Carnitine only

Experimental group

Description:

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

Treatment:

Drug: Acetylcarnitine

Acetyl-L-Carnitine or Placebo

Experimental group

Description:

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

Treatment:

Drug: Acetylcarnitine

Drug: Placebo