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Drug availability
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetyl-L-Carnitine only | Experimental | The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done. |
|
| Acetyl-L-Carnitine or Placebo | Experimental | Subjects 16-30 will be randomized to receive drug or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylcarnitine | Drug | Acetylcarnitine is taken 2 times a day for days 1 through 21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score. | Days 1 - 21 |
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Inclusion Criteria:
Subjects must meet the following inclusion criteria.
Exclusion Criteria:
Subjects will be excluded for the following:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Acetyl-L-Carnitine or Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score. | Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis. | Posted | Days 1 - 21 |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed. Unable to meet enrollment goals. Drug expired prior to being able to enroll total subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chie Schin-Shih | Indiana University | 317-944-8784 | shih2@iu.edu |
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| ID | Term |
|---|---|
| D000108 | Acetylcarnitine |
| ID | Term |
|---|---|
| D002331 | Carnitine |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Placebo | Drug | Placebo is taken 2 times a day for days 1 through 21. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 1 |
| 8 |
| 8 |
| 8 |
| EG001 | 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 | 0 | 0 | 0 |
| Low Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | short of breath |
|
| pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | hip pain |
|
| RASH | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | RASH ON HAND |
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| NEUTROPENIA | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |