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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01353222
Recruitment Status : Terminated (Administrative reasons.)
First Posted : May 13, 2011
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):

Brief Summary:
This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Biological: DN24-02 Other: Standard of Care Phase 2

Detailed Description:
Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
Study Start Date : June 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DN24-02
Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.
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.

Standard of Care
Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Other: Standard of Care
Observation only until documentation of disease recurrence.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months) ]

    Overall survival is defined as the time from randomization to death due to any cause.

    *This study was terminated early due to administrative reasons.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histopathologic evidence of urothelial carcinoma, based on local pathology report.
  • High risk urothelial carcinoma, in subjects with or without prior neoadjuvant chemotherapy, defined as positive lymph node status (N+), or pathological stage ≥ pathological tumor (pT2) in patients who either have negative lymph node status (N0) or have no evaluable lymph nodes (Nx).
  • Radical surgical resection was performed ≤ 84 days (12 weeks) prior to registration.
  • No evidence of residual disease or metastasis following surgical resection which includes: absence of invasive cancer at the margins in the surgical specimens and confirmation by CT scan of chest, abdomen and pelvis obtained at least 28 days following surgical resection and ≤ 28 days prior to registration.
  • HER2/neu tissue expression ≥ 1+ by immunohistochemistry (IHC). Available biopsy specimens from the primary tumor and involved lymph nodes are be submitted to the central pathology laboratory prior to registration for confirmation of HER2/neu tissue expression.
  • Last neoadjuvant chemotherapy treatment administered at least 60 days prior to registration.
  • Left ventricular ejection fraction ≥ 50% on multigated acquisition (MUGA) scan or echocardiogram obtained at least 28 days following surgery and ≤ 28 days prior to registration.
  • Women of child-bearing potential have a negative serum pregnancy test result ≤ 28 days prior to registration and agree not to breastfeed during investigational treatment with DN24-02 and for 28 days following the final infusion of DN24-02.
  • All males and premenopausal females who have not been surgically sterilized have agreed to practice a method of birth control considered by the Investigator to be effective and medically acceptable for at least 14 days prior to registration, throughout treatment, and for 28 days following the final infusion of DN24-02.
  • Adequate hematologic, renal, and liver function.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

  • A history of stage III or greater non-urothelial cancer. Exceptions include: Subject with basal or squamous cell skin cancers that has been adequately treated who are disease-free at the time of registration. Subjects who have been disease-free and off treatment for ≥ 10 years at the time of registration.
  • A history of stage I or II non-urothelial cancer. Exceptions include: Subjects who have been disease-free and off treatment for ≥ 3 years at the time of registration. Subjects with incidental prostate cancer diagnosed at the time of cystoprostatectomy. Subjects with basal or squamous cell skin cancer.
  • Partial cystectomy in the setting of bladder cancer primary tumor.
  • Partial nephrectomy in the setting of renal pelvis primary tumor.
  • Adjuvant systemic therapy for urothelial or prostatic carcinoma following surgical resection.
  • Adjuvant radiation therapy for urothelial or prostatic carcinoma following surgical resection.
  • Incidental prostate cancer with detectable post-operative (radical cystoprostatectomy) prostate specific antigen (PSA) levels ≤ 28 days prior to registration.
  • Any major surgery (e.g., surgery requiring general anesthesia) ≤ 28 days prior to registration.
  • Systemic treatment on any investigational clinical trial ≤ 28 days prior to registration.
  • Systemic glucocorticoid or immunosuppressive therapy use ≤ 28 days prior to registration.
  • Any infection requiring parenteral antibiotic therapy or causing fever (i.e., temperature > 100.5°F or > 38.1°C) ≤ 7 days prior to registration.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DN24-02 or Granulocyte-macrophage colony-stimulating factor (GM-CSF).
  • Any medical intervention, has any other condition, or has any other circumstance which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01353222

  Hide Study Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Genesis Research
San Diego, California, United States, 92123
Stanford University Hospital
Stanford, California, United States, 94305
United States, Colorado
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Connecticut
Neag Comprehensive Cancer Center/University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Urological Research Network
Hialeah, Florida, United States, 33016
University of Miami Cancer Center
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, United States, 33612
United States, Georgia
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
Atlanta, Georgia, United States, 30322
American Red Cross
Atlanta, Georgia, United States, 30324
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City Urology Care
Overland Park, Kansas, United States, 66211
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Michigan Institute of Urology
Troy, Michigan, United States, 48084
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
GU Research Center, LLC
Omaha, Nebraska, United States, 68130
United States, New Jersey
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, United States, 10016
Memorial Sloan Kettering
New York, New York, United States, 10021
Mount Sinai School of Medicine Department of Urology
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medical College
New York, New York, United States, 10065
Associated Medical Professionals of NY, PLLC
Oneida, New York, United States, 13421
University of Rochester Medical Center
Rochester, New York, United States, 14642
Associated Medical Professionals of New York, PLLC
Syracuse, New York, United States, 13210
United States, North Carolina
UNC Health Care, NC Cancer Hospital
Chapel Hill, North Carolina, United States, 27514
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
TriState Urologic Services PSC, Inc. dba TUG Research
Cincinnati, Ohio, United States, 45212
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45219
Jewish Hospital
Cincinnati, Ohio, United States, 45236
The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology
Columbus, Ohio, United States, 43210, 43221, 43212
United States, Oklahoma
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, United States, 74146
United States, Oregon
OHSU Knight Cancer Institute Hematology Oncology
Beaverton, Oregon, United States, 97006
Providence Medical Center
Portland, Oregon, United States, 97213
Oregon Urology Institute
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Urology Health Specialists, LLC
Bryn Mawr, Pennsylvania, United States, 19010
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Sentara Leigh Hospital
Norfolk, Virginia, United States, 23502
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23462
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
UW Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC

Responsible Party: Dendreon Identifier: NCT01353222     History of Changes
Other Study ID Numbers: N10-1
First Posted: May 13, 2011    Key Record Dates
Results First Posted: May 25, 2017
Last Update Posted: May 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dendreon:
Bladder cancer
Renal pelvis cancer
Ureteral cancer
Urethral cancer
Renal pelvis
Immune therapy
Dendritic cells
Antigen-presenting cells
Antigen presenting cells
Cancer vaccine
Urothelial carcinoma
Urothelial neoplasms
Neoplasms by site

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type