This lay summary is intended to provide a general overview of the Children’s Oncology Group study # ACCL 0731. It will provide information about the children that are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the healthcare team in any way. You can find additional information about participation on clinical trials on www.childrensoncologygroup.org. Always discuss any questions that you may have with your healthcare team.

Official Title:ACCL0731 Glutamic Acid to Decrease Vincristine Toxicity in Children with Cancer

Trial Opening Date:This phase three study is expected to accrue 208 patients >= 3 years and < 21 years of age. It opened to enrollment 10/2007 and is expected to continue for 48 months.

General Patient Eligibility:

Please consult your doctor to determine whether your child may participate in this study.

-Patient Age: >= 3 years and < 21years of age

You may be eligible to take part in this study if you:

• Have newly diagnosed ALL, NHL, Wilms’ tumor or rhabdomyosarcoma
• Are scheduled to receive chemotherapy that includes at least 4 weekly doses of Vincristine
• Do not have neuromuscular disease or peripheral neuropathy
• Do not have a seizure disorder
• No regular use of laxatives prior to chemotherapy

Other major enrollment criteria:

• Patient must be enrolled on study prior to beginning therapy
• Must start treatment within 7 days of registration
• Be willing to answer questions about your personal and medical history
• Have a neurological exam 2 or 3 times during the study
• In addition to chemotherapy, take study medicine every day for 5 to 10 weeks depending on the diagnosis
• Mark on a piece of paper every time you take the study medication

-Patients with the following may not be eligible:

• Peripheral neuropathy

Seizure disorders

• Primary intracranial malignancy
• Family history of Charcot Marie Tooth disease
• No Recent history of Guillain-Barre
• Receiving Itraconazole

General Background and Study Goal

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 along with a vincristine containing 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 neurotoxixity observed among those children treated with l-glutamic acid hydrochloride as compared to those 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.

Summary of the Treatment

• Screening, Informed Consent, Enrollment, Baseline Neurologic Exam
• Group 1 Patients with Wilms’ tumor or Rhabdomyosarcoma Group 2 Patients wit ALL or NHL
• Randomization to glutamic acid or placebo
• Begin prior to chemotherapy, while on chemotherapy take 3 times a day, after chemotherapy continue for 7 more days. The medication is a capsule given by mouth.
• Both group 1 and group 2 will receive a week 5 neurologic exam
• Group 2 study complete
• Group 1 only follow-up neurological exam at week 10 then study complete
• Glutamic Acid has a slightly bitter taste but is virtually tasteless when mixed with applesauce, yogurt, or ice cream. Capsules may be opened and mixed with these foods.
• A drug log will be kept to record when the medication is given or if doses are missed

Special Considerations:

This study will not involve extra blood draws or invasive tests. The neurological exams will be performed at your clinic visit by your primary oncologist.

Risks and Side Effects

Chemotherapy can cause short- and long-term side effects. All patients will be closely monitored to reduce the likelihood of negative side effects. All risks and side effects will be explained in detail by your healthcare team during the consent process. They can answer any questions that you may have regarding participation on the clinical trial or other aspects of care. Please refer to the consent document for a detailed explanation of the side effects associated with the treatment on this study.

You may have side effects while on the study. Everyone will be watched carefully for any side effects. We found no reports of frequent or serious side effects. Glutamic acid, when taken in higher doses, may cause nausea. For more information about risks and side effects, ask your study doctor.

Contact Information

Your child’s oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator:

Principal Investigator Name: Scott Bradfield, M.D.
Address: Division of Hematology/Oncology
Nemours Children’s Clinic
807 Children’s Way
Jacksonville, Florida 32207
Phone: 904-390-3793
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.