Phase 3
Completed N=250
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Source: ClinicalTrials.gov NCT00369564 ↗Enrolled (actual)
250
Serious AEs
6.0%
Results posted
Mar 2014
Primary outcomePrimary: Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable) — 26; 34 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable) |
26; 34 | — |
| SECONDARY Number of Participants With Neurotoxicity Observed |
21; 25 | — |
| SECONDARY Ability to Receive All Scheduled Doses of Vincristine |
84; 100 | — |
| SECONDARY Types of Neurotoxicities |
11; 14; 11; 13; 10; 13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00369564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.