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A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Urothelial Carcinoma

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Trial Information

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma


This is a multicenter, open-label, Phase 2 study. Subjects will be randomized to either the
investigational product, DN24-02, or to standard of care. The purpose of this study is to
compare the length of survival between these 2 groups of subjects. Other purposes of the
study are to learn about the safety of DN24-02, to learn if it delays the time until
urothelial cancer recurs, and to learn if the immune system responds to treatment with
DN24-02. All subjects will be followed for this study for the remainder of their lives.


Inclusion Criteria:



- Histopathologic evidence of urothelial carcinoma at high risk of recurrence.

- Radical surgical resection was performed ≤ 84 days (12 weeks) prior to registration.

- No evidence of residual disease or metastasis on 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 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 have 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) 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate overall survival following administration of DN24-02

Outcome Time Frame:

Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 5 years)

Safety Issue:

No

Principal Investigator

Robert Sims, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dendreon

Authority:

United States: Food and Drug Administration

Study ID:

N10-1

NCT ID:

NCT01353222

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Urothelial Carcinoma
  • Bladder cancer
  • Renal pelvis cancer
  • Ureteral cancer
  • Urethral cancer
  • Bladder
  • Renal pelvis
  • Ureter
  • Urethra
  • Immune therapy
  • Immunotherapy
  • Vaccine
  • Dendritic cells
  • Antigen-presenting cells
  • Antigen presenting cells
  • Cancer vaccine
  • Urothelial carcinoma
  • Urothelial neoplasms
  • Neoplasms by site
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Mount Sinai School of Medicine New York, New York  10029
Virginia Mason Medical Center Seattle, Washington  98111
University of Rochester Medical Center Rochester, New York  14642
City of Hope Medical Center Duarte, California  91010
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Mayo Clinic Hospital Phoenix, Arizona  85054-4502
Michigan Institute of Urology Detroit, Michigan  48236
University of Minnesota Minneapolis, Minnesota  55455
Duke University Durham, North Carolina  27710
University of Chicago Medical Center Chicago, Illinois  60637
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Dana Farber Cancer Institute Boston, Massachusetts  02115
Lahey Clinic Burlington, Massachusetts  01805
Urological Associates Of Lancaster Lancaster, Pennsylvania  17604-3200
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231
Jewish Hospital Cincinnati, Ohio  45236
Indiana University Indianapolis, Indiana  46202
Mayo Clinic Arizona Scottsdale, Arizona  85259
University of Kansas Cancer Center Kansas City, Kansas  66160
Columbia University Medical Center New York, New York  10032
Johns Hopkins Hospital Baltimore, Maryland  21287
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Memorial Sloan Kettering New York, New York  10021
Oregon Urology Institute Springfield, Oregon  97477
Stanford University Hospital Stanford, California  94303
University of Miami Cancer Center Miami, Florida  33136
The Urology Center of Colorado Denver, Colorado  80211
Providence Medical Center Portland, Oregon  97213
H. Lee Moffitt Cancer Center & Research Institute, Inc. Tampa, Florida  33612
University of Wisconsin Carbone Cancer Center Madison, Wisconsin  53792-5669
Mount Sinai School of Medicine Department of Urology New York, New York  10029
Urological Research Network Hialeah, Florida  33016
Urology Health Specialists, LLC Bryn Mawr, Pennsylvania  19010
Genesis Research San Diego, California  92123
Associated Medical Professionals of New York, PLLC Oneida, New York  13421
TriState Urologic Services PSC, Inc. dba TUG Research Cincinnati, Ohio  45212
Urology Associates, P.C. Nashville, Tennessee  37209
Kansas City Urology Care Overland Park, Kansas  66211
Dana-Farber Cancer Institute - The Lank Center for Genitourinary Oncology Boston, Massachusetts  02215
Sentara Leigh Hospital Norfolk, Virginia  23502
Urology of Virginia, PLLC Virginia Beach, Virginia  23462
University of Colorado, Anschutz Cancer Pavilion Aurora, Colorado  80045
Neag Comprehensive Cancer Center/University of Connecticut Health Center Farmington, Connecticut  06030
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital Atlanta, Georgia  30322
American Red Cross Atlanta, Georgia  30324
GU Research Center, LLC Omaha, Nebraska  68130
John Theurer Cancer Center, Hackensack University Medical Center Hackensack, New Jersey  07601
NYU Clinical Cancer Center, NYU Langone Medical Center New York, New York  10016
Associated Medical Professionals of NY, PLLC Oneida, New York  13421
UNC Health Care, NC Cancer Hospital Chapel Hill, North Carolina  27514
Hoxworth Blood Center Cincinnati, Ohio  45219
OHSU Knight Cancer Institute Hematology Oncology Beaverton, Oregon  97006