Phase 2
N=15
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00659984 ↗Enrolled (actual)
15
Serious AEs
33.3%
Results posted
Mar 2017
Primary outcome: Primary: Maximum Tolerated Dose — 18.6 mCi/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- UltratraceTM Iobenguane I 131 Imaging (Drug); UltratraceTM Iobenguane I 131 Therapy (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
18.6 | — |
| SECONDARY Dose Limiting Toxicities |
0; 0; 0 | — |
| SECONDARY Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions |
16.7; 12.7; 11.1 | — |
| SECONDARY Overall Objective Tumor Response Post Therapeutic Treatment |
0.29 | — |
| SECONDARY Tumor Response in CT/MRI Lesions Post Therapeutic Treatment |
21 | — |
| SECONDARY Quality of Life |
5.2 | 0.363 |
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.
Eligibility 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..
Data sourced from ClinicalTrials.gov (NCT00659984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.