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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Childrens Hospital Los Angeles
Los Angeles, California, United States
Lucile Salter Packer Children's Hospital
Palo Alto, California, United States
Objective Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Time frame: 43-50 days from study day 1
Number of Participants With Grade 3 or Greater Non-hematologic Toxicities
Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG
Time frame: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months
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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
...and 4 more locations