An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
Trial Status: complete
This study will compare three treatment regimens containing metaiodobenzylguanidine
(MIBG) and compare their effects on tumor response and associated side effects, to
determine if one therapy is better than the other for people diagnosed with relapsed or
persistent neuroblastoma.
Inclusion Criteria
Patients must be > 24 months and < 30 years of age when registered on study.
Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.
Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable CD34+ cells/kg available.
Exclusion Criteria
They have had previous I-131 MIBG therapy
They have other medical problems that could get much worse with this treatment.
They are pregnant or breast feeding.
They have a history of a venous or arterial thrombosis that was not associated to a central line.
They have active infections such as hepatitis or fungal infections.
They have active diarrhea.
They have had an allogeneic stem cell transplant (received stem cell from someone else)
They can't cooperate with the special precautions that are needed for this trial.
Additional locations may be listed on ClinicalTrials.gov for NCT02035137.
Locations matching your search criteria
United States
California
Los Angeles
Children's Hospital Los Angeles
Status: Active
Name Not Available
Georgia
Atlanta
Children's Healthcare of Atlanta - Arthur M Blank Hospital