131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03649438|
Expanded Access Status : Temporarily not available
First Posted : August 28, 2018
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment|
|Relapsed Neuroblastoma Metastatic Pheochromocytoma||Drug: 131 I-Metaiodobenzylguanidine Drug: Potassium Iodide Drug: G-csf|
Primary Objective is to provide access to therapy with 131I-MIBG for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma.
Secondary Objectives are to (1) assess disease response to 131I-MIBG therapy for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma; (2) gain more information about the toxicities of 131I-MIBG therapy; and (3) assess improvement of symptoms, including pain and fatigue, for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are receiving 131I-MIBG therapy.
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|Official Title:||131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma|
- Drug: 131 I-Metaiodobenzylguanidine
Other Name: 131I-MIBG
- 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.
- Dose of 12 mCi/kg for patients without a stem cell source with normal renal function and meets other eligibility criteria.
- Dose of > 12 mCi/kg to 18 mCi/kg maximum at investigator's discretion for patients meeting eligibility criteria with stem cells available.
- Drug: Potassium Iodide
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.Other Name: KI solution
- 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). This will start 24 hours after stem cell infusion (if stem cells are to be infused).Other Name: Neulasta
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649438
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Tanya Watt, MD||University of Texas Southwestern Medical Center|