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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00107289
First received: April 5, 2005
Last updated: January 9, 2015
Last verified: January 2015
  Purpose

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Giving iodine I 131 metaiodobenzylguanidine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine works in treating patients with recurrent, progressive, or refractory neuroblastoma or malignant pheochromocytoma or paraganglioma.


Condition Intervention Phase
Neuroblastoma
Pheochromocytoma
Radiation: iobenguane I 131
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Response (complete or partial) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between tumor self-absorbed dose and response and tumor volume decrease [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2006
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation 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.


Detailed Description:

OBJECTIVES:

Primary

  • Utilize targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG) in treating patients with recurrent, progressive, or refractory neuroblastoma (NB) or malignant chromaffin cell tumors (CCT).
  • Determine the response rate in patients with NB treated with this regimen.
  • Determine, preliminarily, the toxicity and efficacy of this regimen in patients with malignant CCT.

Secondary

  • Determine the whole-body dosimetry of ^131I-MIBG in these patients.
  • Determine the tumor dosimetry of ^131I-MIBG in patients with measurable soft tissue disease.

OUTLINE: This is an open-label, pilot study.

Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 1-4 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107289

Contacts
Contact: Ellen Basu, MD, PhD 212-639-5204
Contact: Shakeel Modak, MD 212-639-7623

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ellen Basu, MD, PhD         
Contact: Shakeel Modak, MD    212-639-7623      
Principal Investigator: Ellen Basu, MD, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Ellen Basu, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00107289     History of Changes
Other Study ID Numbers: 04-148, MSKCC-04148
Study First Received: April 5, 2005
Last Updated: January 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center:
metastatic pheochromocytoma
recurrent pheochromocytoma
regional pheochromocytoma
recurrent neuroblastoma
04-148

Additional relevant MeSH terms:
Pheochromocytoma
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neuroendocrine Tumors
Paraganglioma
3-Iodobenzylguanidine
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on April 26, 2015