New York, New York 10065


Purpose:

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.


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 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. 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.


NCT ID:

NCT00107289


Primary Contact:

Principal Investigator
Ellen Basu, MD, PhD
Memorial Sloan Kettering Cancer Center

Ellen Basu, MD, PhD
Phone: 212-639-5204


Backup Contact:

Shakeel Modak, MD
Phone: 212-639-7623


Location Contact:

New York, New York 10065
United States

Ellen Basu, MD, PhD
Phone: 212-639-5204

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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