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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Neuroblastoma; Pheochromocytoma

Treatments: Drug: iobenguane I 131

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00107289

MSKCC-04148

04-148

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Radiation

Experimental group

Description:

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.

Treatment:

Drug: iobenguane I 131