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Study Description

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.

(From NANT website - https://www.nant.org/n2011-01/)

The purpose of this study is to compare three different treatments using the investigational medicine called ¹³¹I-Metaiodobenzylguanidine (MIBG).  MIBG is taken up by neuroblastoma tumor cells, and can be combined together with radioactive iodine ¹³¹ in the laboratory to form the radioactive compound ¹³¹I-MIBG. The ¹³¹I-MIBG compound delivers radiation treatment when it is taken up by neuroblastoma cancer cells throughout the body.   Although testing in laboratories has found that adding other agents can improve the response of neuroblastoma tumor cells to 131 I-MIBG, it is not known if adding other agents to the 131 I-MIBG will increase the number of tumors in patients that will respond to the therapy.  

The three treatment arms on this study are:  1) 131 I-MIBG alone, 2) 131 I-MIBG with Irinotecan and Vincristine, or 3) 131 I-MIBG with Vorinostat.  Patients on all treatment arms will receive autologous (their own) stem cells as part of this therapy.  All three 131 I-MIBG treatment regimens have already been used for the treatment of neuroblastoma and shown tumor responses, and their tolerated doses have been determined.  This study will compare the number of tumor responses seen with each of the three different treatment arms.

Once patients are registered on this study, they will be randomly assigned to one of the three treatment arms.  Random assignment means that the assignment is based on chance. It is like a flip of a coin, and assignment is done by a computer. Neither patients nor their physicians will choose the treatment. All patients will have an equal chance of being assigned to each of the three treatment arms. A total of 105 patients are expected to enroll on this study. There will be 35 patients on each treatment arm.

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.