Recruiting
Phase 2

Iodine I 131 Metaiodobenzylguanidine

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT00107289

Conditions

Neuroblastoma

Pheochromocytoma

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

iobenguane I 131

Study Details

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.

Conditions

Neuroblastoma

Pheochromocytoma

Study ID

NCT00107289

Start date

May, 2006

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation

Patients will be treated with IV 131I-MIBG using 1-2 high dose(s) or up to 16 low doses.

Thyroid protection is commenced seven days (+/-2 days) prior to administration of 131I-MIBG and continued for up to 42 days after each 131I-MIBG treatment. Given that this is an open access protocol, re-enrollment is allowed per PI discretion. Patients who received this treatment previously are allowed to be re-enrolled if they meet the eligibility criteria. Re-enrollment can be to the same arm previously treated on (high dose versus low dose) or to the other arm. Patients will not be eligible for re-enrollment if they have already received 16 low doses or 4 high doses of 131I-MIBG.

Interventions

iobenguane I 131

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 outcome measure

  • Response (complete or partial) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Ellen Basu, MD, PhD

212-639-5204

Shakeel Modak, MD

212-639-7623

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ellen Basu, MD, PhD

212-639-5204

Shakeel Modak, MD

212-639-7623

Principal Investigator:

Ellen Basu, MD, PhD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • metastatic pheochromocytoma
  • recurrent pheochromocytoma
  • regional pheochromocytoma
  • recurrent neuroblastoma
  • 04-148

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.