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

Primary Purpose

Neuroblastoma, Pheochromocytoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
iobenguane I 131
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring metastatic pheochromocytoma, recurrent pheochromocytoma, regional pheochromocytoma, recurrent neuroblastoma, 04-148

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

Outcomes

Primary Outcome Measures

Response (complete or partial)

Secondary Outcome Measures

Correlation between tumor self-absorbed dose and response and tumor volume decrease

Full Information

First Posted
April 5, 2005
Last Updated
June 14, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00107289
Brief Title
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
Official Title
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2006 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Pheochromocytoma
Keywords
metastatic pheochromocytoma, recurrent pheochromocytoma, regional pheochromocytoma, recurrent neuroblastoma, 04-148

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
iobenguane I 131
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response (complete or partial)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlation between tumor self-absorbed dose and response and tumor volume decrease
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Basu, MD, PhD
Phone
212-639-5204
First Name & Middle Initial & Last Name or Official Title & Degree
Shakeel Modak, MD
Phone
212-639-7623
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Basu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Basu, MD, PhD
Phone
212-639-5204
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Phone
2126393046
Email
pandit-n@MSKCC.ORG
First Name & Middle Initial & Last Name & Degree
Ellen Basu, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26773712
Citation
Chu BP, Horan C, Basu E, Dauer L, Williamson M, Carrasquillo JA, Pandit-Taskar N, Modak S. Feasibility of Administering High-Dose (131) I-MIBG Therapy to Children with High-Risk Neuroblastoma Without Lead-Lined Rooms. Pediatr Blood Cancer. 2016 May;63(5):801-7. doi: 10.1002/pbc.25892. Epub 2016 Jan 15.
Results Reference
derived
PubMed Identifier
26742708
Citation
Modak S, Zanzonico P, Carrasquillo JA, Kushner BH, Kramer K, Cheung NK, Larson SM, Pandit-Taskar N. Arsenic Trioxide as a Radiation Sensitizer for 131I-Metaiodobenzylguanidine Therapy: Results of a Phase II Study. J Nucl Med. 2016 Feb;57(2):231-7. doi: 10.2967/jnumed.115.161752. Epub 2016 Jan 7.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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