Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

Neuroblastoma Clinical Trial

Official title:

Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00107289
• Other study ID #: 04-148
• Secondary ID: MSKCC-04148
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Ellen Basu, MD, PhD
• Phone: 212-639-5204
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion criteria for NB:

• Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.

• Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.

• Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol

• Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.

• Age >1 year with a determination that radiation safety restrictions during therapy period can be implemented.

• Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• Minimum life expectancy of eight weeks

• Signed informed consent indicating awareness of the investigational nature of this program.

Inclusion criteria for malignant CCT:

• Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma

• Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol

• Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.

• Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period

• Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• Minimum life expectancy of eight weeks.

• Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

• Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.

• Active serious infections not controlled by antibiotics.

• Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.

• Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

Related Conditions & MeSH terms

• Neuroblastoma
• Pheochromocytoma

Intervention

Radiation:
• iobenguane I 131
Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 µCi/mL, patients may undergo autologous stem cell transplantation. After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response (complete or partial)		2 years
Secondary	Correlation between tumor self-absorbed dose and response and tumor volume decrease		2 years

External Links

•   Memorial Sloan Kettering Cancer Center