TriangleNCT00369564 · STUDY IN CONTEXT
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified "Balis" Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms.
Number of participants with neurotoxicity observed treated with l-glutamic acid hydrochloride as compared to the number of participants with neurotoxicity observed in the placebo control group
We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group
Types of neurotoxicities reported. Each patient was only counted once for each type of neurotoxicity, but a patient could be counted in more than 1 type of neurotoxicity. For example, if a patient experienced constipation 3 times, they are included once for constipation. If a patient experienced sensory changes and motor changes, they are included once for sensory changes and once for motor changes.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- trial label
- Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0000
- source section id
- NCT00369564-om-0000
- source outcome index
- 0
- endpoint
- Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)
- endpoint definition
- A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified "Balis" Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms.
- time origin
- 10 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients reporting baseline and post-baseline observation
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0001
- source section id
- NCT00369564-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Neurotoxicity Observed
- endpoint definition
- Number of participants with neurotoxicity observed treated with l-glutamic acid hydrochloride as compared to the number of participants with neurotoxicity observed in the placebo control group
- time origin
- 10 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Stratum 2 with a \>= grade 2 neurotoxicity
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0002
- source section id
- NCT00369564-om-0002
- source outcome index
- 2
- endpoint
- Ability to Receive All Scheduled Doses of Vincristine
- endpoint definition
- We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group
- time origin
- 10 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Number in stratum 1 and stratum 2 that completed
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0003
- source section id
- NCT00369564-om-0003
- source outcome index
- 3
- endpoint
- Types of Neurotoxicities
- endpoint definition
- Types of neurotoxicities reported. Each patient was only counted once for each type of neurotoxicity, but a patient could be counted in more than 1 type of neurotoxicity. For example, if a patient experienced constipation 3 times, they are included once for constipation. If a patient experienced sensory changes and motor changes, they are included once for sensory changes and once for motor changes.
- time origin
- 10 Weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who returned a post baseline Neurotox Questionnaire
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I Glutamic Acid
- regimen
- Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- analyzed count
- 97
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II Placebo
- regimen
- Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- analyzed count
- 107
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I Glutamic Acid
- regimen
- Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). glutamic acid: Given orally 3 times daily
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II Placebo
- regimen
- Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). placebo: Given orally 3 times daily
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I Glutamic Acid
- regimen
- Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a total of 1500 mg/day of oral glutamic acid .
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II Placebo
- regimen
- Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent. Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). .
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I Glutamic Acid
- regimen
- Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II Placebo
- regimen
- Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00369564-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- harm key
- EG000
- source section id
- NCT00369564-ae
- event group key
- EG000
- event group label
- Arm I Glutamic Acid
- serious affected
- 9
- serious at risk
- 127
- other affected
- 16
- other at risk
- 127
- frequency threshold
- 5
- collection period
- 10 weeks
- event definition
- Subjects and parents completed daily study medication logs and noted any adverse events or symptoms. Site personnel reviewed study medication logs with subjects to assess for adverse events and completed an in-person neurological exam and chemistry profile at weeks 5 and 10 to assess for adverse events. Adverse events reviewed by independent DSMB.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-kidney-carcinoma
- nct id
- NCT00369564
- harm key
- EG001
- source section id
- NCT00369564-ae
- event group key
- EG001
- event group label
- Arm II Placebo
- serious affected
- 6
- serious at risk
- 123
- other affected
- 5
- other at risk
- 123
- frequency threshold
- 5
- collection period
- 10 weeks
- event definition
- Subjects and parents completed daily study medication logs and noted any adverse events or symptoms. Site personnel reviewed study medication logs with subjects to assess for adverse events and completed an in-person neurological exam and chemistry profile at weeks 5 and 10 to assess for adverse events. Adverse events reviewed by independent DSMB.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice