Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Condition: Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma
MeSH terms: Lymphoma; Leukemia; Sarcoma; Kidney Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: Glutamine; Placebo
Intervention description: Administered orally twice daily for 21 days; Administered orally twice daily for 21 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 5 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage II childhood small noncleaved cell lymphoma; stage I Wilms tumor; stage II Wilms tumor; stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; childhood grade III lymphomatoid granulomatosis; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; stage I childhood large cell lymphoma; stage I childhood lymphoblastic lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; stage IV childhood lymphoblastic lymphoma; stage IV childhood small noncleaved cell lymphoma; childhood Burkitt lymphoma; stage III childhood small noncleaved cell lymphoma; untreated childhood acute lymphoblastic leukemia; childhood nasal type extranodal NK/T-cell lymphoma; previously untreated childhood rhabdomyosarcoma; localized Ewing sarcoma/PNET; metastatic Ewing sarcoma/PNET; neurotoxicity; peripheral neuropathy

Summary:

      RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known
      whether glutamine is more effective than a placebo in treating neuropathy caused by
      vincristine.

      PURPOSE: This randomized phase II trial is studying glutamine to see how well it works
      compared to a placebo in treating neuropathy caused by vincristine in young patients with
      lymphoma, leukemia, or solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between the age of 5 and 21 years old.

          -  Patients who demonstrate the ability to complete the assessment instruments at
             baseline.

          -  Patients who are diagnosed with leukemia or solid tumors and are expected to receive a
             cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine
             doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week
             period.

        Exclusion Criteria:

          -  Patients with primary CNS tumors other than medulloblastoma or patients with CNS
             metastasis.

          -  Patients with recurrent disease.

          -  Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on
             clinical exam.

          -  Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual
             vincristine doses are capped at 2mg according to primary cancer treatment protocol,
             during their course of therapy at time of consent.

          -  Patients with hepatic encephalopathy or hyperammonemia.

          -  Patients with a focally abnormal neurologic exam.