Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Kidney Cancer, Leukemia, Lymphoma
About this trial
This is an interventional supportive care trial for Kidney Cancer focused on measuring neurotoxicity, peripheral neuropathy, stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, previously untreated childhood rhabdomyosarcoma, childhood grade III lymphomatoid granulomatosis, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, stage I childhood large cell lymphoma, stage II childhood large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, childhood Burkitt lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, untreated childhood acute lymphoblastic leukemia
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.
Sites / Locations
- Lee Cancer Care of Lee Memorial Health System
- Butterworth Hospital at Spectrum Health
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- Hackensack University Medical Center Cancer Center
- Blumenthal Cancer Center at Carolinas Medical Center
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I Glutamic Acid
Arm II Placebo
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).
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).