Status:
COMPLETED
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
Lead Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief 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 transpla...
Detailed Description
OBJECTIVES: Primary * To establish the maximum tolerated dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) in patients with relapsed/refractory high-risk neuroblastoma. Secondary * To des...
Eligibility Criteria
Inclusion
- 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
- 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..
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00659984
Start Date
June 1 2008
End Date
November 1 2010
Last Update
October 4 2017
Active Locations (8)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
2
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
4
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637