DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
- Conditions
- Urothelial Carcinoma
- Interventions
- Biological: DN24-02Other: Standard of Care
- Registration Number
- NCT01353222
- Lead Sponsor
- Dendreon
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 142
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DN24-02 DN24-02 Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions. Standard of Care 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.
- Primary Outcome Measures
Name Time Method Overall Survival 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Stanford University Hospital
🇺🇸Stanford, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
OHSU Knight Cancer Institute Hematology Oncology
🇺🇸Beaverton, Oregon, United States
American Red Cross
🇺🇸Atlanta, Georgia, United States
Urological Research Network
🇺🇸Hialeah, Florida, United States
NYU Clinical Cancer Center, NYU Langone Medical Center
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Urologic Specialists of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology
🇺🇸Columbus, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Associated Medical Professionals of New York, PLLC
🇺🇸Syracuse, New York, United States
Associated Medical Professionals of NY, PLLC
🇺🇸Oneida, New York, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Urology Health Specialists, LLC
🇺🇸Bryn Mawr, Pennsylvania, United States
Sentara Leigh Hospital
🇺🇸Norfolk, Virginia, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Miami Cancer Center
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
GU Research Center, LLC
🇺🇸Omaha, Nebraska, United States
Mount Sinai School of Medicine Department of Urology
🇺🇸New York, New York, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
UW Medical Center
🇺🇸Seattle, Washington, United States
Genesis Research
🇺🇸San Diego, California, United States
Jewish Hospital
🇺🇸Cincinnati, Ohio, United States
TriState Urologic Services PSC, Inc. dba TUG Research
🇺🇸Cincinnati, Ohio, United States
Hoxworth Blood Center
🇺🇸Cincinnati, Ohio, United States
Kansas City Urology Care
🇺🇸Overland Park, Kansas, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Urology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
University of Colorado, Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Providence Medical Center
🇺🇸Portland, Oregon, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Neag Comprehensive Cancer Center/University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
John Theurer Cancer Center, Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
UNC Health Care, NC Cancer Hospital
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States