N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG.

PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria:

• Patients must be at least one year and no more than 30 years of age when registered on this study.

• Patients must have high risk neuroblastoma and either have tumor left after treatment started at diagnosis or have had the tumor grow back (relapsed) after getting some treatment

• Patients must an MIBG scan done and it must be positive for neuroblastoma.

• Patients must have a PBSC or bone marrow stem cell product available that meets study criteria. If they don't already have stem cells frozen away then they must be able to have a stem cell pheresis done to collect the necessary amount of stem cells for study entry and these stem cells must meet study criteria.

• Patients must have adequate heart, lung, liver, kidney and bone marrow function.

Exclusion Criteria:

• They have had a stem cell transplant using another person as the stem cell donor. (You can still be in the study if a previous transplant used your own stem cells)

• They have other medical problems that could get much worse if they had this treatment.

• They are on dialysis for badly working kidneys or have other kidney problems.

• They are pregnant or breast feeding.

• They have tumor in the brain or spinal cord that is seen on a CT or MRI scan one month before starting treatment

• They had total body radiation or radiation to the entire belly.

• They have a known allergy to MIBG, iodine or SSKI.

• They can't cooperate with the special precautions that are needed during UltratraceTM MIBG treatment or with other safety monitoring requirements of the study..