Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Melda Dolan, MD
CONTACT
Chinmay Bhavsar
CONTACT
Lead
Jubilant DraxImage Inc.
Primary Objectives: * To provide 131I-MIBG for compassionate use in patients with neuroblastoma, who otherwise do not qualify for inclusion or cannot participate in the sponsor's pivotal Phase II, FDA-approved, clinical trial. * To provide 131I-MIBG for compassionate use in patients with neuroblastoma in the absence of a commercially available FDA approved product for the indication. * Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma. * To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, not qualifying for FDA-approved MIBG treatment. * To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, in the absence of a commercially available FDA-approved product for that indication. * Gain more information about acute and late toxicity of 131I-MIBG therapy for patients with refractory neuroblastoma, pheochromocytoma, or paraganglioma. Patients will receive a therapeutic dose at the investigator's discretion (5-18 mCi/kg). However, a dose of 12 mCi/kg or higher requires stored stem cells. Patients may be eligible for additional 131I-MIBG treatments (up to a cumulative total of 3 treatments) if they meet certain criteria. Treatments with 131I-MIBG must be separated by a minimum of six weeks from previous 131I-MIBG therapy. Post-treatment evaluation will be performed 5-9 weeks (35-63 days) post treatment, and patients will be followed every 6 months until 2 years from therapy. All patients will have toxicity monitoring for 2 years following 131I-MIBG therapy, or until going off study.
Age
1–any
Sex
ALL
Healthy volunteers
Not accepted
