Description:
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.
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.
Recruiting
Phase 2
Name | Type | Description | Interventions |
---|---|---|---|
Radiation | Experimental |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Response (complete or partial) |
Time Frame: | 2 years |
Safety Issue: | |
Description: |
Measure: | Correlation between tumor self-absorbed dose and response and tumor volume decrease |
Time Frame: | 2 years |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
January 11, 2021