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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Apr 5, 2005

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Iodine I 131 Metaiodobenzylguanidine (131 I-MIBG) for patients with difficult-to-treat neuroblastoma, malignant pheochromocytoma, or paraganglioma. The goal is to find out how effective and safe this treatment is for patients whose cancer has come back or has not responded well to other therapies. The trial is currently looking for participants aged 1 to 21 who have specific types of cancer that can be seen on special imaging scans, and who have already tried other treatments without success.

To be part of this study, participants need to meet certain criteria, such as having a diagnosis confirmed by medical professionals and being able to follow safety guidelines during treatment. They also need to have enough stem cells stored for future use after the treatment. Throughout the study, participants will receive the investigational drug and will be monitored for any side effects or changes in their condition. It's important to note that this treatment is still being tested, so all participants must understand this and give their permission before joining the trial.

Gender

ALL

Eligibility 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 with a 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.