131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00293319|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : August 18, 2014
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: filgrastim Radiation: iobenguane I 131||Phase 2|
- Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
- Determine the acute and late toxicity of this regimen in these patients.
- Determine disease and symptom responses of patients treated with this regimen.
OUTLINE: This is a compassionate use study.
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study|
|Study Start Date :||April 2005|
|Primary Completion Date :||March 2006|
|Study Completion Date :||March 2006|
- Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
- Acute and late toxicities
- Disease and symptom responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293319
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Katherine K. Matthay, MD||University of California, San Francisco|
|OverallOfficial:||John M. Maris, MD||Children's Hospital of Philadelphia|
|OverallOfficial:||Robert Goldsby, MD||University of California, San Francisco|