Spots Global Cancer Trial Database for MIBG With Dinutuximab +/- Vorinostat
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Trial Identification
Brief Title: MIBG With Dinutuximab +/- Vorinostat
Official Title: A Phase I Study of 131I-MIBG With Dinutuximab +/- Vorinostat for Relapsed/Refractory Neuroblastoma
Study ID: NCT03332667
Conditions
Study Description
Brief Summary: 131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.
Detailed Description: 131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. Data from pre-clinical and adult studies suggest that radiation can enhance the efficacy of immunotherapy and targeted therapies such as dinutuximab. This first pediatric phase 1 trial of 131I-MIBG in combination with dinutuximab and vorinostat aims to determine the recommended phase 2 pediatric dose of these three therapies in combination.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, 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
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Contact Details
Name: Thomas Cash, MD
Affiliation: Children's Healthcare of Atlanta
Role: STUDY_CHAIR
Name: Araz Marachelian, MD, MS
Affiliation: Children's Hospital Los Angeles
Role: STUDY_DIRECTOR
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