NCT00369564 · REGISTRY CONDITION SEARCH

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2021-08-11

RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is not yet known whether glutamic acid is more effective than a placebo in preventing nerve damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works compared to a placebo in reducing nerve damage caused by vincristine in young patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)

→

outcome · POSTED

Number of Participants With Neurotoxicity Observed

→

outcome · POSTED

Ability to Receive All Scheduled Doses of Vincristine

→

outcome · POSTED

Types of Neurotoxicities

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: INCLUSION CRITERIA: * Patients ≥ 3 and \< 21 years of age at the time of study registration. * Patients newly diagnosed with Wilm's tumor and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen. * Patients newly diagnosed with rhabdomyosarcoma and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen. * Patients newly diagnosed with ALL and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy. * Patients newly diagnosed with Non- Hodgkins Lymphoma (NHL) and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy. * Patients with no underlying neuromuscular disease or peripheral neuropathy EXCLUSION CRITERIA: * Abnormal baseline peripheral neurologic exam (i.e. or peripheral neuropathy) * Patients with: * seizure disorders * primary intracranial malignancy * family history of Charcot Marie Tooth Disease * a recent history of GuillianBarré26 * Patients receiving concomitant itraconazole are at risk for increased vincristine toxicity and therefore are ineligible. * Patients who are regularly using laxatives or stool softeners for constipation at the time of enrollment are not eligible to participate in the study. Likewise, since prevention of neuro-constipation will be evaluated, patients with an ongoing history of constipation that has required frequent use of laxatives or stool softeners should not be enrolled. * Patients should not be scheduled to receive laxatives or stool softeners prophylactically to prevent constipation, as the prevention of neuro-constipation will be evaluated in this study; however, when patients show signs of developing constipation while on chemotherapy, as determined by the treating physician, they may be treated with laxatives or stool softeners at the clinician's discretion. Use of laxatives or stool softeners will be documented on the concomitant medication log.
healthy Volunteers: false
maximum Age: 20 Years
minimum Age: 3 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
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).
intervention Names
Drug: glutamic acid
label
Arm I Glutamic Acid
type
EXPERIMENTAL
description
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).
intervention Names
Other: placebo
label
Arm II Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I Glutamic Acid
description
Given orally 3 times daily
name
glutamic acid
other Names
l-glutamic acid hydrochloride
type
DRUG
arm Group Labels
Arm II Placebo
description
Given orally 3 times daily
name
placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 250
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)
time Frame
10 weeks

secondary Outcomes

description
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
measure
Number of Participants With Neurotoxicity Observed
time Frame
10 weeks
description
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
measure
Ability to Receive All Scheduled Doses of Vincristine
time Frame
10 weeks
description
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.
measure
Types of Neurotoxicities
time Frame
10 Weeks

Full study description

brief Summary: RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is not yet known whether glutamic acid is more effective than a placebo in preventing nerve damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works compared to a placebo in reducing nerve damage caused by vincristine in young patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.
detailed Description: OBJECTIVES: Primary * Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as measured by a scored neurologic examination, in young patients undergoing vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma. Secondary * Compare the frequency and types of neurotoxicity observed in patients treated with glutamic acid versus placebo. * Determine if a greater proportion of patients receiving glutamic acid are able to receive 100% of their scheduled doses of vincristine versus those not treated with glutamic acid. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease and duration of planned vincristine-containing treatment (Wilms' tumor or rhabdomyosarcoma with treatment planned for ≥ 9 consecutive weeks \[stratum 1\] vs acute lymphoblastic leukemia or non-Hodgkin's lymphoma with treatment planned for ≥ 4 consecutive weeks \[stratum 2\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine. * Arm II: Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine. All patients undergo neurologic examination at baseline and at 5 weeks. Patients in stratum 1 also undergo additional neurologic examination at week 10. PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-33d7e9f5ddc40036c108
requested nct id
NCT00369564
primary nct id
NCT00369564
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Kidney+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
0f0b1d47d700cf556d6212d53b7849c30874e411dbc1a4cfc2cbeef7e5d70ca8
payload sha256
eb3dba0ea012569baaa9b9e7ecdbda972fd183eacf20b27ddf6fdc97379f0b0c
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-33d7e9f5ddc40036c108
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00369564
occurrences
context exact
NCT00369564
end
11
exact text
NCT00369564
start
0
offset unit
unicode_code_points
query cond
Childhood Kidney Tumors
query disease state id
ds-childhood-kidney-tumors
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-kidney-tumors-000.json
source file sha256
0f0b1d47d700cf556d6212d53b7849c30874e411dbc1a4cfc2cbeef7e5d70ca8
source json pointer
/studies/23/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
21cb73a92da48639ce76057d0b32416e33ca4109486c986011adbca7412ccdec
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Kidney+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice