Vincristine Induced NeuropathyPhase 2ALCNCT02598622
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
A Phase 2 study testing Acetylcarnitine in people with Vincristine Induced Neuropathy, run by Indiana University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Vincristine Induced Neuropathy
- What is being tested?
- Acetylcarnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Vincristine Induced Neuropathy
- Being tested
- Acetylcarnitine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcarnitineDrug
Acetylcarnitine is taken 2 times a day for days 1 through 21.
PlaceboDrug
Placebo is taken 2 times a day for days 1 through 21.
| Study group | Role | What they receive |
|---|---|---|
| Acetyl-L-Carnitine only | Experimental | The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done. Receives: Drug: Acetylcarnitine |
| Acetyl-L-Carnitine or Placebo | Experimental | Subjects 16-30 will be randomized to receive drug or placebo. Receives: Drug: Acetylcarnitine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
Measured: Days 1 - 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionJan 2016
Why it stopped: Drug availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vincristine Induced NeuropathyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chie-Schin Shih, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598622
- Sponsor's protocol ID
- 1011003177
- Acronym
- ALC
- Status last verified
- Feb 2017
- First submitted
- 25 Aug 2015
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
- ClinicalTrials.gov ID
- NCT02598622
- Acronym / sponsor ID
- ALC / 1011003177
- Conditions
- Vincristine Induced Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug availability
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-L-Carnitine only | Experimental | Drug: AcetylcarnitineThe first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done. |
| Acetyl-L-Carnitine or Placebo | Experimental | Drug: Acetylcarnitine, Drug: PlaceboSubjects 16-30 will be randomized to receive drug or placebo. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects must meet the following inclusion criteria.
Key exclusion criteria (10 listed)
- Subjects will be excluded for the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetylcarnitineAcetylcarnitine is taken 2 times a day for days 1 through 21. | Drug | Acetyl-L-Carnitine only, Acetyl-L-Carnitine or Placebo |
| PlaceboPlacebo is taken 2 times a day for days 1 through 21. | Drug | Acetyl-L-Carnitine or Placebo |
Primary outcome
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
Time frame: Days 1 - 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vincristine Induced Neuropathy
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Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.
Neuropathy, Cancer
Active, not recruitingObservational study
Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetylcarnitine in people with Vincristine Induced Neuropathy, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score. (time frame: Days 1 - 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.