NCT02378428: MIBG

MIBG Therapy for Patients With MIBG Avid Tumors

Active, enrolled Phase 2 Last updated 13 May 2025

What this trial tests

Phase 2 trial testing MIBG in MIBG Avid Tumors in 65 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2014

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Nationwide Children's Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	1 March 2014
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• MIBG — full drug profile →

Conditions studied

• MIBG Avid Tumors — all drugs for MIBG Avid Tumors →

Sponsor

Nationwide Children's Hospital

Who can join

Adults 12 Months to 65, any sex, with MIBG Avid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase II study for patients with MIBG avid tumors. The study is to determine the response rate to \<131\>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating the tolerability and safety of the study agent by evaluating the hematopoietic and non-hematopoietic toxicity of \<131\>I-MIBG therapy. Tumor response will be evaluated by comparing the patient's disease pre-treatment against the patient's day +42 post \<131\>I-MIBG treatment. The evaluations may include the following: \<131\>I-MIBG scan, CT or MRI, urine catecholamine, bone marrow analyses and any other tests considered standard of care for cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG avid. Patients must also have a stem cell source for autologous rescue in the event of protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an alternative. This study will provide data for future clinical trials utilizing \<131\>I-MIBG therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety components to accomodate this treatment. \<131\>I metaiodobenzlguanidine (\<131\>I-MIBG) is a radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and other neuroendocrine tumors. \<131\>I-MIBG was subsequently used as an therapeutic agent for these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with \~50% of patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic toxicities have been mild. Most recently, trials have been conducted combining the study agent with myeloablative chemotherapy and stem cell reinfusion have been performed with initial response rates of \~50%.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiopharmaceutical therapy in cancer: clinical advances and challenges.
   Sgouros G, Bodei L, McDevitt MR, Nedrow JR. · · 2020 · cited 551× · PMID 32728208 · DOI 10.1038/s41573-020-0073-9
2. Novel Therapies for Relapsed and Refractory Neuroblastoma.
   Zage PE. · · 2018 · cited 39× · PMID 30384486 · DOI 10.3390/children5110148
3. Emerging therapeutic targets for neuroblastoma.
   Aravindan N, Herman T, Aravindan S. · · 2020 · cited 20× · PMID 33021426 · DOI 10.1080/14728222.2020.1790528