131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

Completed · Phase 2

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID: NCT02035137
Run by: New Approaches to Neuroblastoma Therapy Consortium
People needed: 114
Starts: 2014-07-01
Expected to finish: 2021-02-26
Last updated by the study team: 2022-06-08

Who can join

Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Childrens Hospital Los Angeles — Los Angeles, California, United States
Lucile Salter Packer Children's Hospital — Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
Children Hospital of Colorado — Aurora, Colorado, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus — Atlanta, Georgia, United States
University of Chicago, Comer Children's Hospital — Chicago, Illinois, United States
Children's Hospital Boston — Boston, Massachusetts, United States
C.S Mott Children's Hospital — Ann Arbor, Michigan, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Cook Children's Healthcare System — Fort Worth, Texas, United States
Seattle Children's Hospital — Seattle, Washington, United States
Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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