Iobenguane I-131 in Treating Patients with Recurrent Neuroblastoma, Malignant Pheochromocytoma, or Malignant Paraganglioma
This phase II trial studies the side effects of targeted radiation therapy with iobenguane I-131 and to see how well it works in treating patients with neuroblastoma that has come back or has not responded to treatment, or pheochromocytoma or paraganglioma that has spread to other places in the body. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells.
Inclusion 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 Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (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. Exceptions include: daily oral inhibitors (i.e., lorlatinib or trametinib) that can be given throughout protocol treatment and oral histone deacetylase (HDAC) inhibitors vorinostat that may be initiated just prior to treatment and continued after treatment
- Age > 1 year with a determination that radiation safety restrictions during therapy period can be implemented
- Stem cells: patients for high dose 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 x 10^6 CD34+ cells/kg
- Minimum life expectancy of eight weeks
- Signed informed consent indicating awareness of the investigational nature of this program
- INCLUSION CRITERIA FOR CCT: Patients must have the diagnosis of malignant chromaffin cell tumor (CCT) i.e. malignant pheochromocytoma or malignant paraganglioma
- INCLUSION CRITERIA FOR CCT: Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
- INCLUSION CRITERIA FOR CCT: At least 2 weeks should have elapsed since any biologic therapy; three weeks should have elapsed since last dose of chemotherapy
- INCLUSION CRITERIA FOR CCT: Age ≥ 1 years old and able to cooperate with radiation safety restrictions during therapy period
- INCLUSION CRITERIA FOR CCT: Stem cells: Patients for high dose 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 x 10^6 CD34+ cells/kg
- INCLUSION CRITERIA FOR CCT: Minimum life expectancy of eight weeks
- INCLUSION CRITERIA FOR CCT: 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; 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
Additional locations may be listed on ClinicalTrials.gov for NCT00107289.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVES:
I. To utilize iobenguane I-131 (iodine 131 [131I]-metaiodobenzylguanidine [MIBG]) to treat patients with resistant neuroblastoma (NB).
II. To estimate response rates to 131I-MIBG therapy in patients with resistant NB.
III. To provide preliminary data on the toxicity and efficacy of 131I-MIBG in patients with malignant chromaffin cell tumors (CCT).
OUTLINE:
Patients receive potassium iodide orally (PO) and liothyronine PO on days -7 to 42 and high dose iobenguane I-131 intravenously (IV) over 15 minutes to 4 hours on day 0. Patients may receive a second dose of high dose iobenguane I-131 6-8 weeks after the first dose in the absence of disease progression or unacceptable toxicity. Patients unable to tolerate high dose may receive low dose iobenquane every 6-16 weeks for up to 8 doses. Patients who receive a second dose, also receive liothyronine PO daily for 3 days before the second dose to 14 days after the second dose. Patients also receive potassium iodide PO daily for 3 days before the second dose to 42 days after each dose of iobenquane. Patients may also undergo computed tomography (CT), magnetic resonance imaging (MRI), bone scan, positron emission tomography (PET), echocardiography, bone marrow biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed for up to 45 days, then yearly.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEllen M. Basu
- Primary ID04-148
- Secondary IDsNCI-2016-00955
- ClinicalTrials.gov IDNCT00107289