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
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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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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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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