NCT01850888

MIBG for Refractory Neuroblastoma and Pheochromocytoma

131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Refractory Neuroblastoma and Pheochromocytoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a best available therapy/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Patients may receive a range of doses depending on stem cell availability and tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death will be evaluated.

Detailed description

Primary Objective is to provide access to therapy with 131I-MIBG for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma. Secondary Objective is to assess disease response to 131I-MIBG therapy for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma. Tertiary Objectives are to 1) gain more information about the toxicities of 131I-MIBG therapy; 2) assess improvement of symptoms, including pain and fatigue, for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are receiving 131I-MIBG therapy. * The therapeutic dose of 131I-MIBG will be based on the following: 1. Minimum dose of 10 mCi/kg for patients without a stem cell source whose renal function is above the upper limit of normal but still meets eligibility criteria. 2. Dose of 12 mCi/kg for patients without a stem cell source with normal renal function and meets other eligibility criteria. 3. Dose of \> 12 mCi/kg to 18 mCi/kg maximum at investigator's discretion for patients meeting eligibility criteria with stem cells available. * A urinary catheter and intravenous fluids will be used for bladder protection, and potassium iodide solution for thyroid Protection. * G-CSF is recommended for patients with ANC less than 750 after MIBG infusion. * hematopoietic stem cell infusion is recommended for patients with grade 4 hematologic toxicity following 131I-MIBG therapy that continues to have an ANC \<200 on G-CSF without signs of recovery for \>2 weeks and any patient requiring platelet transfusion more than two times weekly for 4 consecutive weeks. * Follow-up will be done until disease progression, death or other therapies are initiated.

Conditions

• Relapsed Neuroblastoma
• Metastatic Pheochromocytoma

Interventions

Type	Name	Description
DRUG	131 I-Metaiodobenzylguanidine (131I-MIBG)	Minimum dose of 10 mCi/kg and up to 18 mCi/kg maximum will be diluted in 25 ml of normal saline, and will be infused intravenously over 90-120 minutes.
DRUG	Potassium iodide solution	For the therapeutic MIBG administration, potassium iodide solution will be administered in a loading dose of 6mg/kg orally at least 8 hours prior to the MIBG injection, and then will be given at 1mg/kg/dose every 4 hours on days 0-6, then 1 mg/kg/day through day 45 post injection. The minimum dose of potassium iodide to be given is one drop, which equals 50 mg.
DRUG	G-CSF	It is recommended that patients with ANC less than 750 after MIBG infusion begin G-CSF 5 mcg/kg/day subcutaneously (or receive equivalent single dose of Neulasta every 14 days while neutropenic) until neutrophil recovery (generally \>5000).
PROCEDURE	hematopoietic stem cell infusion	The majority of patients on this protocol will have autologous PBSCs available. Allogeneic stem cells may be utilized in patients who has received a prior allogeneic transplant. The minimum quantity for peripheral blood stem cells is 1.5 x 106 CD34+ cells/kg (optimum \> 2 x 106 CD34+ cells/kg). The minimum dose for bone marrow is 1.0 x 108 mononuclear cells/kg (optimum \>2.0 x 108 mononuclear cells/kg). Infusion will be performed according to institutional guidelines.

Timeline

• Start date: 2013-12-01
• Primary completion: 2025-10-20
• Completion: 2025-10-20
• First posted: 2013-05-10
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States