What? Study Title - Trial Name

A Phase II, Open Label, Two-Arm Study of Therapeutic Iobenguane (I131) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUMTM TRIAL)

Where? Study Locations

The study is currently running across the US and the 20 trial sites listed below are open to enroll more HRNB patients. Click here to register to connect with the clinical team of your choice.

Why? Purpose of the Study

To determine the efficacy and safety of I-131 MIBG treatment in combination with vorinostat in subjects with iobenguane avid, recurrent or progressive high-risk neuroblastoma.

How? Protocol Summary - What The Trial Involves

The study is conducted in the United States and will include up to 70 high-risk neuroblastoma patients. Eligible patients will receive up to two cycles of vorinostat, once daily for 14 days, and I-131 MIBG treatment (as a single infusion per cycle).

Participation in the study may involve up to 14 visits over a 2 1/2-year period, depending on the number of treatment cycles received and the response to treatment.

Basic Eligibility Criteria​

Patients 1 year of age or older
May have had prior I-131 MIBG therapy
Diagnosis of iobenguane avid high-risk neuroblastoma
Refractory, recurrent or progressive disease

US Site Locations Where The Study / Trial Is Conducted

Dana-Farber/Boston Children’s Cancer and Blood Disorders Center

Address: 450 Brookline Ave, Boston, MA 02215

Contact: Catherine M Clinton, MS

Phone: 617-632-5556

Children's Hospital of Philadelphia

Address: 3401 Civic Center Blvd, Philadelphia, PA 19104

Contact: Yael Mosse, MD

Phone: 215-590-0965

UPMC Children’s Hospital of Pittsburgh

Address: One Children’s Hospital Drive, 4401 Penn Ave, Pittsburgh, PA 15224

Contact: Doreen Snelsire

Phone: 412-692-8864

Atrium Health

Address: 1001 Blythe Blvd, Charlotte, NC 28203

Contact: Katherine Farmer

Phone: 704-641-7350

Nemours Children’s Health

Address: 6535 Nemours Parkway, Orlando, FL 32827

Contact: Manisha M Bansal, MD

Phone: 904-697-3793

Cincinnati Children's Hospital Medical Center

Address: 3333 Burnet Avenue, Cincinnati, Ohio 45229-3026

Contact: Lori Backus

Phone: 513-636-2047

University of Wisconsin, American Family Children’s Hospital

Address: 1675 Highland Ave, Madison, WI 53792

Contact: Jenny Weiland

Phone: 608-890-8070

University of Chicago

Address: 5841 S Maryland Ave, Chicago, IL 60637

Contact: Melissa Z Marx, MPH

Phone: 773-702-2927

University of Iowa

Address: 200 Hawkins Drive, Iowa City, IA 52242

Contact: Roxanne Mitten

Phone: 319-356-1212

Washington Univ. Medical Center St. Louis

Address: One Children’s Place, St. Louis, MO 63110

Contact: Sally Jones, MA, CCRP

Phone: 314-454-4353

University of Minnesota

Address: 425 East River Parkway, Minneapolis, MN 55455

Contact: Ashley Schempp, MPH

Phone: 612-625-9340

Cook Children's Health Care System

Address: 801 7th Ave, Fort Worth, TX 76104

Contact: Juli Ramirez

Phone: 682-885-2580

Children’s Health

Address: 1935 Medical District Drive, Dallas, TX 75235

Contact: Beverly Kleiber, PhD, CCRP

Phone: 246-456-1003

Texas Children's Hospital

Address: 6621 Fannin St, Houston, TX 77030

Contact: Akudo Anyanwu

Phone: 832-824-4167

Children’s Hospital Colorado

Address: 4090 Briargate Parkway, Colorado Springs, CO 80920

Contact: Astrid Eder

Phone: 720-777-8531

University of California

Address: 1825 Fourth St., San Francisco, CA 94158

Contact: Debbie Lara

Phone: 415-476-2218

Seattle Children's Hospital

Address: 4800 Sand Point Way NE, Seattle, WA 98105

Contact: Christine Goetz, BA, CCRC

Phone: 206-884-1149

Northwell Health / Cohen Children's Medical Center

Address: 269-01 76th Ave, Queens, NY 11040

Contact: Eva Atsidaftos

Memorial Sloan Kettering Cancer Center

Address: 1275 York Ave, New York, NY 10065

Contact: Ellen M Basu, MD, PhD

Phone: 212-639-5204

Stanford University

Address: 777 Welch Rd, Palo Alto, CA 94304

Contact: Elizabeth Reichert, PhD

Phone: 650-724-8842

About High-Risk Neuroblastoma

High-risk neuroblastoma is a difficult to treat childhood cancer and those children with resistant or relapsed disease, after current standard of care is exhausted, have poor prognosis.

Jubilant Radiopharma is proud to be a leader in the development of therapeutics intended to treat rare and serious conditions including neuroblastoma. These efforts are aligned with the value that nuclear medicine can bring to improve precise, patient-focused treatment.

NOTE: Therapeutic MIBG labeled with I-131 is not approved by the USFDA or Health Canada

For more information, scan the QR code or refer to ClinicalTrials.gov
Identifier: NCT03561259