Protocol No.PO10312
JDI2007-01
Principal InvestigatorHoover-Regan, Margo
PhaseN/A
Age GroupBoth
ClinicalTrials.GovNCT01590680 (Click to jump to clinicaltrials.gov)
Management Group(s) Pediatric Oncology

Title
An open label, expanded access protocol using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients with Refractory, High-Risk Neuroblastoma, Pheochromocytoma, or Paraganglioma

Description
Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG for patients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do not qualify for available treatments, or where approved treatment is not commercially available.

Objective
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.

Treatment Radiation: I-131 MIBG
The therapeutic dose (5-18 mCi/kg at investigator's discretion; any dose ≥12 mCi/kg requires stored stem cells) will be diluted in normal saline, and will be infused intravenously over 90-120 minutes.
Other Names:



    I-131 Iobenguane

    I-131 meta-iodobenzylguanidine

Key Eligibility For full study eligibility, please see this study's ClinicialTrials.gov record.

Applicable Disease Sites
Neuroblastoma

Participating Institutions
UW Health University Hospital