131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol
ConditionNeuroblastoma
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age1+
SponsorKieuhoa Vo
About this trial
This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative access to 131I-metaiodobenzylguanidine (131I-MIBG).
Eligibility criteria
Qualifiers
Diagnosis: Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical tumor cells in the bone marrow. Refractory, progressive or metastatic pheochromocytoma/paraganglioma or related tumor.
MIBG uptake: Tumors must be shown to be MIBG avid within 6 weeks prior to enrollment
Age > 1 year and able to cooperate with radiation safety restrictions during therapy period. Patients with pheochromocytoma/paraganglioma and related tumors must be between 1 and 12 years of age.
Life Expectancy: greater than 6 weeks.
Disqualifiers
Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Study Chair or Vice Chair prior to patient entry.
Because of the teratogenic potential of the study medications, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible pregnancy.
Patients who are on hemodialysis.
Patients with active infections that meet grade 3-4 toxicity criteria.
Trial design
Treatments tested in this trial
- Metaiodobenzylguanidine (MIBG)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Kieuhoa Vo
Lead sponsor
University of California, San Francisco
Sponsor institution
Cannonball Kids' Cancer Foundation
Collaborator
Source ClinicalTrials.gov