Vincristine Induced Neuropathy
Conditions
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.
Interventions
DRUGAcetylcarnitine
Acetylcarnitine is taken 2 times a day for days 1 through 21.
DRUGPlacebo
Placebo is taken 2 times a day for days 1 through 21.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score. | Days 1 - 21 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acetyl-L-Carnitine Only The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21. | 8 |
| Acetyl-L-Carnitine or Placebo Subjects 16-30 will be randomized to receive drug or placebo.
Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.
Placebo: Placebo is taken 2 times a day for days 1 through 21. | 0 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Acetyl-L-Carnitine Only | Total |
|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Age, Continuous | 8 years | 8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 0 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 0 / 0 |
| serious Total, serious adverse events | 1 / 8 | 0 / 0 |
Outcome results
Primary
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
Time frame: Days 1 - 21
Population: Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.