Back to resultsA Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL (ALC)
Primary Purpose
Vincristine Induced Neuropathy
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetylcarnitine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vincristine Induced Neuropathy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acetyl-L-Carnitine only
Acetyl-L-Carnitine or Placebo
Arm Description
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Subjects 16-30 will be randomized to receive drug or placebo.
Outcomes
Primary Outcome Measures
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02598622
Brief Title
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Acronym
ALC
Official Title
A Phase II Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Drug availability
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vincristine Induced Neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetyl-L-Carnitine only
Arm Type
Experimental
Arm Description
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Arm Title
Acetyl-L-Carnitine or Placebo
Arm Type
Experimental
Arm Description
Subjects 16-30 will be randomized to receive drug or placebo.
Intervention Type
Drug
Intervention Name(s)
Acetylcarnitine
Intervention Description
Acetylcarnitine is taken 2 times a day for days 1 through 21.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is taken 2 times a day for days 1 through 21.
Primary Outcome Measure Information:
Title
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
Time Frame
Days 1 - 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
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