I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
- 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.
Masking: Open Label, Primary Purpose: Treatment
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
Katherine K. Matthay, MD
University of California, San Francisco
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|