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Study Chair: Scott Bradfield,M.D.
Eric Sandler, M.D.
Status: Approved by NCI
Activation Date: 03/16/07
Study Objectives:
The primary objective of this study is to determine if, over a brief observation period of 5-10 weeks, patients treated with l-glutamic acid hydrochloride in conjunction with a vincristine-containing treatment regimen have a statistically significant decrease in neurotoxicity as compared to those in the placebo control group as measured by a scored neurologic examination.
Secondary objectives are to determine the frequency and types of neurotoxicity observed among those children treated with l-glutamic acid hydrochloride as compared to those who are in the placebo control group. Also, we will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group.
Inclusion Criteria:
- Patients, ages 3 through 20, 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 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
- Signed research authorization to release PHI to the Moffitt CCOP Research Base must be obtained prior to registration.
- Signed informed consent must be obtained prior to registration
Exclusion Criteria:
- Abnormal baseline peripheral neurologic exam (i.e. or peripheral neuropathy)
- sizure disorders
- primary intracranial maligancy
- family history of Charcot Marie Tooth Disease
- a recent history of Guillian Barre
- Patients receiving concomitant itraconazole are at risk for increased vincristine toxicity and therefore are ineligible.
- Patients regularly receiving laxatives prior to chemotherapy.
- In order to patient to be dually enrolled on other investigational protocols, the study committee of the investigational protocol must adopt HLMCC 0402 as a supportive care study. However, patients may not be enrolled on other investigational protocols where they would receive any other study agent that is provided under an IND.