Post-Marketing Assessment of Immunogenicity and Safety of Unituxin™ in High-Risk Neuroblastoma Patients



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 18
Updated:7/14/2016
Start Date:March 2016
End Date:December 2018
Contact:Robert Staszewski, MA
Email:rstaszewski@unither.com
Phone:919-425-8190

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A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin™ in High-Risk Neuroblastoma Patients

The purpose of this study is to assess the incidence of human anti-chimeric antibody (HACA)
in high-risk neuroblastoma patients treated with Unituxin combination therapy.

This is a multi-center, non-randomized, open-label study in patients with high-risk
neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination
therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of
high-risk neuroblastoma.

Inclusion Criteria:

- Patient has been diagnosed with high-risk neuroblastoma.

- Patient has been prescribed Unituxin and plans to start Unituxin therapy within 30
days of study entry.

- Patient must start Unituxin therapy no later than 200 days after Autologous Stem Cell
Transplantation (ASCT).

- Written informed consent / assent must be obtained in accordance with institutional
and ICH guidelines.

Exclusion Criteria:

- Patient has received prior anti-GD2 antibody therapy.

- Patient has participated in an investigational clinical trial with tumor therapeutic
intent within 30 days of informed consent.

- Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days
prior to receiving Unituxin therapy.
We found this trial at
10
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Stuart Cramer, MD
Phone: 205-638-2984
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Susan Cohn, MD
Phone: 773-702-2927
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Araz Marachelian, MD
Phone: 323-361-8029
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Howard Katzenstein, MD
Phone: 615-936-3316
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Elyssa Rubin, MD
Phone: 714-509-7868
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Janet Yoon, MD
Phone: 858-966-8966
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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San Diego, CA
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Ann Arbor, Michigan 94143
Principal Investigator: Rajen Mody, MD
Phone: 734-763-6344
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Ann Arbor, MI
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Kathleen Neville, MD
Phone: 501-364-4181
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Principal Investigator: Jawhar Rawwas, MD
Phone: 612-813-7419
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Minneapolis, MN
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Allice Lee, MD
Phone: 212-305-8630
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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