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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

Neuroblastoma

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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