Research Study Summary
131I-MIBG Expanded Access: An Open Label, Expanded Access Protocol Using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients With Refractory Neuroblastoma
What is the purpose of this study?
The goals of this research study are:
- To make 131I-MIBG therapy available to patients with advanced neuroblastoma
- To further assess the side effects of 131I-MIBG therapy
Who will be included in this study?
Patients who are greater than 1 year who have relapsed or resistant neuroblastoma may be eligible to participate in this study.
What is involved?
Before patients can participate in this study, they will take part in a screening process that will include:
- Physical exam
- Blood and Urine tests to evaluate kidney, liver, bone marrow and thyroid function
- MIBG Scan (scan used to identify neuroblastoma that is present in the body)
- CT Scan (a form of x-ray imaging)
- MRI (magnetic resonance imaging
- Bone marrow aspirate and biopsy (involves the removal of cells from the central portion of the bone)
- Pregnancy test for females of childbearing age
One treatment cycle of 131I-MIBG therapy is 7 to 9 weeks long. The patient will be evaluated to receive additional 131I-MIBG therapy at the end of each cycle. If they qualify and their blood counts are good, it is possible that they could receive a total of three treatment cycles, for a total of 21 to 27 weeks. Hospitalization is required for approximately 3 to 5 days after each dose.
The following tests are all necessary to make sure that patients are not having unsafe side effects of 131I-MIBG:
- Physical exam
- Blood tests
- Urine tests
- Scans to evaluate the tumor (the doctor will determine the best type of scan, e.g. CT scan, MRI and/or MIBG scan)
What are the benefits?
There may or may not be a direct medical benefit to the patient. The 131I-MIBG treatment used in this research study is not intended to cure the patient of their neuroblastoma. The potential benefit from participation in this research might be stopping tumor growth, reducing the size of the tumor(s), relieving symptoms caused by the tumor(s), and prolonging life. However, this cannot be guaranteed. We hope the information learned from this study will benefit other patients with neuroblastoma in the future.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.
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