131-I-MIBG Therapy for Hard-to-Treat Neuroblastoma: Expanded Access Program
Sponsor: John Maris
ClinicalTrials ID:NCT01163383
This study offers a special treatment using a radioactive compound, 131 I-MIBG, to target and kill neuroblastoma cancer cells. It aims to provide access to this therapy while collecting data on its effectiveness and safety.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
131 I-MIBG is a treatment that combines a substance called MIBG with radioactive iodine to specifically target and kill neuroblastoma cancer cells. This study allows patients to receive this treatment when needed and helps researchers gather information on how well it works and its side effects. A recent study showed that adding different drugs to 131 I-MIBG can affect its success rate, with one combination showing a 75% response rate after two cycles. The study also found that one combination had more side effects, while another had no significant serious side effects. Vorinostat, a drug used in adults for a different type of cancer, is being tested in this study but is not yet approved for neuroblastoma.
Description
131 I-MIBG is an experimental treatment used in over 100 children in the U.S. to treat relapsed neuroblastoma. It has shown some success in shrinking tumors, but it can lower the number of healthy blood cells temporarily. Before starting treatment, patients will undergo tests like lab work, scans, and physical exams to ensure they are eligible. A tube will be placed in a vein to administer the treatment, and a urinary catheter may be used to manage radioactive urine. Patients will stay in a special room with lead shielding to protect others from radiation. Family members can visit but must wear a radiation badge. The treatment involves receiving 131 I-MIBG through a vein over 1-2 hours, with regular monitoring of blood pressure and heart rate. Patients will take potassium iodide to protect the thyroid and have regular blood tests to check health. If the tumor responds well, additional treatment cycles may be offered. If blood counts drop, medications like G-CSF or Neulasta may be given to boost white blood cells. Vorinostat may be used as part of the treatment plan, taken daily for 14 days with food.
Eligibility Criteria
Inclusion Criteria
- Have neuroblastoma that is hard to treat or has returned after treatment.
- Be older than 1 year.
- Be able to perform daily activities with a performance status of 50% or higher.
- Have cancer that has not responded to standard treatments or has worsened.
- Have a stem cell product available for use after treatment if needed.
- Have recovered from any previous treatments and not be receiving other cancer therapies.
- Have acceptable liver and kidney function based on specific blood tests.
- Provide written consent to participate.
Exclusion Criteria
- Have a major organ disease that would make treatment unsafe.
- Be pregnant or breastfeeding, and must use birth control if of childbearing potential.
- Be on hemodialysis.
- Have uncontrolled infections.
- Exceptions to these criteria may be allowed if approved by the study leader and do not compromise safety.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.