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NCT Number: NCT00107289

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

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Ellen Basu, MD, PhD

CONTACT

212-639-5204

Ellen Basu, MD, PhD

PRINCIPAL_INVESTIGATOR

Shakeel Modak, MD

CONTACT

212-639-7623

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Determination that radiation safety restrictions during therapy period can be implemented.
  • Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. 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.

Treatment and study plan

iobenguane I 131

Drug

A single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours or for 15 minutes for smaller patients 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. In some scenarios, extended time will be allowed before the second dose of 131I-MIBG for additional recovery and possible bridging therapy. 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. Once patients are off treatment on this protocol, they will begin long term follow up through 5 years from enrollment.

Primary outcomes

  1. Response (complete or partial)

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Basu, MD, PhD

CONTACT

212-639-5204

Shakeel Modak, MD

CONTACT

212-639-7623

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2005
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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