DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Urothelial Carcinoma
Interventions
BIOLOGICAL

DN24-02

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

OTHER

Standard of Care

Observation only until documentation of disease recurrence.

Trial Locations (60)

10016

NYU Clinical Cancer Center, NYU Langone Medical Center, New York

10021

Memorial Sloan Kettering, New York

10029

Mount Sinai School of Medicine Department of Urology, New York

Mount Sinai School of Medicine, New York

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medical College, New York

13210

Associated Medical Professionals of New York, PLLC, Syracuse

13421

Associated Medical Professionals of NY, PLLC, Oneida

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

19010

Urology Health Specialists, LLC, Bryn Mawr

19107

Thomas Jefferson University, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

21287

Johns Hopkins Hospital, Baltimore

23462

Urology of Virginia, PLLC, Virginia Beach

23502

Sentara Leigh Hospital, Norfolk

27514

UNC Health Care, NC Cancer Hospital, Chapel Hill

27710

Duke University, Durham

29425

Medical University of South Carolina, Charleston

30322

Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital, Atlanta

30324

American Red Cross, Atlanta

33016

Urological Research Network, Hialeah

33136

University of Miami Cancer Center, Miami

33612

H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa

37209

Urology Associates, P.C., Nashville

37232

Vanderbilt University Medical Center, Nashville

45212

TriState Urologic Services PSC, Inc. dba TUG Research, Cincinnati

45219

Hoxworth Blood Center, Cincinnati

45236

Jewish Hospital, Cincinnati

46202

Indiana University, Indianapolis

48084

Michigan Institute of Urology, Troy

53792

University of Wisconsin Carbone Cancer Center, Madison

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60637

University of Chicago Medical Center, Chicago

66205

University of Kansas Cancer Center, Westwood

66211

Kansas City Urology Care, Overland Park

68130

GU Research Center, LLC, Omaha

74146

Urologic Specialists of Oklahoma, Tulsa

77030

The University of Texas MD Anderson Cancer Center, Houston

80045

University of Colorado, Anschutz Cancer Pavilion, Aurora

80211

The Urology Center of Colorado, Denver

85054

Mayo Clinic Hospital, Phoenix

85259

Mayo Clinic Arizona, Scottsdale

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Medical Center, Duarte

92123

Genesis Research, San Diego

94305

Stanford University Hospital, Stanford

97006

OHSU Knight Cancer Institute Hematology Oncology, Beaverton

97213

Providence Medical Center, Portland

97477

Oregon Urology Institute, Springfield

98101

Virginia Mason Medical Center, Seattle

98195

UW Medical Center, Seattle

06030

Neag Comprehensive Cancer Center/University of Connecticut Health Center, Farmington

06520

Yale University School of Medicine, New Haven

02215

Dana Farber Cancer Institute, Boston

01805

Lahey Clinic, Burlington

07601

John Theurer Cancer Center, Hackensack University Medical Center, Hackensack

43210, 43221, 43212

The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology, Columbus

Sponsors

Lead Sponsor

All Listed Sponsors
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INDUSTRY