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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 add

Первичные конечные точки

• Response (complete or partial) [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Correlation between tumor self-absorbed dose and response and tumor volume decrease [Срок оценки: 2 years]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Memorial Sloan Kettering Cancer Center — New York

Публикации

• 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. PMID 26773712
• 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. PMID 26742708

Идентификаторы

NCT: NCT00107289 · 04-148 · MSKCC-04148

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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