Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Condition: Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma
MeSH terms: Lymphoma; Kidney Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: glutamic acid; placebo
Intervention description: Given orally 3 times daily; Given orally 3 times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 3 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: 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

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.
    

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.