Study Stopped
Administrative reasons.
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
1 other identifier
interventional
142
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Typical duration for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 25, 2017
CompletedMay 25, 2017
April 1, 2017
4.1 years
May 4, 2011
March 8, 2017
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.
Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)
Study Arms (2)
DN24-02
EXPERIMENTALSubjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.
Standard of Care
OTHERSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (60)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
City of Hope Medical Center
Duarte, California, 91010, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Genesis Research
San Diego, California, 92123, United States
Stanford University Hospital
Stanford, California, 94305, United States
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Neag Comprehensive Cancer Center/University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Urological Research Network
Hialeah, Florida, 33016, United States
University of Miami Cancer Center
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, 33612, United States
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
Atlanta, Georgia, 30322, United States
American Red Cross
Atlanta, Georgia, 30324, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Kansas City Urology Care
Overland Park, Kansas, 66211, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
GU Research Center, LLC
Omaha, Nebraska, 68130, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, 10016, United States
Memorial Sloan Kettering
New York, New York, 10021, United States
Mount Sinai School of Medicine Department of Urology
New York, New York, 10029, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Associated Medical Professionals of NY, PLLC
Oneida, New York, 13421, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210, United States
UNC Health Care, NC Cancer Hospital
Chapel Hill, North Carolina, 27514, United States
Duke University
Durham, North Carolina, 27710, United States
TriState Urologic Services PSC, Inc. dba TUG Research
Cincinnati, Ohio, 45212, United States
Hoxworth Blood Center
Cincinnati, Ohio, 45219, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology
Columbus, Ohio, 43210, 43221, 43212, United States
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, 74146, United States
OHSU Knight Cancer Institute Hematology Oncology
Beaverton, Oregon, 97006, United States
Providence Medical Center
Portland, Oregon, 97213, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Urology Health Specialists, LLC
Bryn Mawr, Pennsylvania, 19010, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Sentara Leigh Hospital
Norfolk, Virginia, 23502, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
UW Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shabnam Vaziri
- Organization
- Dendreon
Study Officials
- STUDY DIRECTOR
Robert Israel, MD
Valeant Pharmaceuticals North America LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 13, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
May 25, 2017
Results First Posted
May 25, 2017
Record last verified: 2017-04