Status:
COMPLETED
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Children's Oncology Group
Conditions:
Kidney Cancer
Leukemia
Eligibility:
All Genders
3-20 years
Phase:
PHASE3
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 patient...
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-co...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00369564
Start Date
May 1 2007
End Date
November 1 2012
Last Update
August 11 2021
Active Locations (6)
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1
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
2
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503-2560
3
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
4
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601