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A Pilot Phase II Study of Targeted Radiotherapy with ¹³¹I-MIBG and Arsenic Trioxide in Patients with Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

[Protocol 04-148]

Full Title :

PILOT PHASE II STUDY OF TARGETED RADIOTHERAPY WITH 131 I-METAIODOBENZYLGUANIDINE (131 I-MIBG) IN PATIENTS WITH RESISTANT NEUROBLASTOMA OR MALIGNANT CHROMAFFIN CELL TUMORS

Purpose :

Metaiodobenzylguanidine (MIBG) is a substance that is taken up specifically by neuroblastoma, pheochromocytoma, or paraganglioma tumor cells. MIBG can be combined together with radioactive iodine (¹³¹I) in the laboratory to form the radioactive compound ¹³¹I-MIBG. The ¹³¹I-MIBG compound concentrates more in cancer cells than in normal cells, and may therefore deliver more radiation directly to cancer cells while sparing normal organs.

Arsenic trioxide is a drug that has been shown to kill neuroblastoma cells in the laboratory. It has been used safely in children and adults with various cancers. In laboratory studies, arsenic trioxide was more effective against cancer cells when given with radioactivity delivered specifically to the tumor.

The purpose of this research study is to assess the safety and effectiveness of the combination of ¹³¹I-MIBG and arsenic trioxide in patients with neuroblastoma, malignant pheochromocytoma, or malignant paraganglioma that has returned or is resistant to standard treatments.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a diagnosis of neuroblastoma, malignant pheochromocytoma, or malignant paraganglioma that has returned or is resistant to standard treatments.
• At least 2 weeks must have passed since prior biological therapy and 3 weeks since prior chemotherapy and entry into the trial.
• Patients with neuroblastoma must be older than 1 year of age. Patients with malignant pheochromocytoma or malignant paraganglioma must be between the ages of 1 and 21.

For more information and to see if your child is eligible for this study, please contact Dr. Shakeel Modak at 212-639-7623.