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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 InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mount Sinai School of MedicineNew York, New York  10029
Virginia Mason Medical CenterSeattle, Washington  98111
University of Rochester Medical CenterRochester, New York  14642
City of Hope Medical CenterDuarte, California  91010
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Mayo Clinic HospitalPhoenix, Arizona  85054-4502
Michigan Institute of UrologyDetroit, Michigan  48236
University of MinnesotaMinneapolis, Minnesota  55455
Duke UniversityDurham, North Carolina  27710
University of Chicago Medical CenterChicago, Illinois  60637
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Lahey ClinicBurlington, Massachusetts  01805
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231
Jewish HospitalCincinnati, Ohio  45236
Indiana UniversityIndianapolis, Indiana  46202
Mayo Clinic ArizonaScottsdale, Arizona  85259
University of Kansas Cancer CenterKansas City, Kansas  66160
Columbia University Medical CenterNew York, New York  10032
Johns Hopkins HospitalBaltimore, Maryland  21287
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Memorial Sloan KetteringNew York, New York  10021
Oregon Urology InstituteSpringfield, Oregon  97477
Stanford University HospitalStanford, California  94303
University of Miami Cancer CenterMiami, Florida  33136
The Urology Center of ColoradoDenver, Colorado  80211
Providence Medical CenterPortland, Oregon  97213
H. Lee Moffitt Cancer Center & Research Institute, Inc.Tampa, Florida  33612
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669
Mount Sinai School of Medicine Department of UrologyNew York, New York  10029
Urological Research NetworkHialeah, Florida  33016
Urology Health Specialists, LLCBryn Mawr, Pennsylvania  19010
Genesis ResearchSan Diego, California  92123
Associated Medical Professionals of New York, PLLCOneida, New York  13421
TriState Urologic Services PSC, Inc. dba TUG ResearchCincinnati, Ohio  45212
Urology Associates, P.C.Nashville, Tennessee  37209
Kansas City Urology CareOverland Park, Kansas  66211
Dana-Farber Cancer Institute - The Lank Center for Genitourinary OncologyBoston, Massachusetts  02215
Sentara Leigh HospitalNorfolk, Virginia  23502
Urology of Virginia, PLLCVirginia Beach, Virginia  23462
University of Colorado, Anschutz Cancer PavilionAurora, Colorado  80045
Neag Comprehensive Cancer Center/University of Connecticut Health CenterFarmington, Connecticut  06030
Emory Department of Urology, The Emory Clinic Inc, Emory University HospitalAtlanta, Georgia  30322
American Red CrossAtlanta, Georgia  30324
GU Research Center, LLCOmaha, Nebraska  68130
John Theurer Cancer Center, Hackensack University Medical CenterHackensack, New Jersey  07601
NYU Clinical Cancer Center, NYU Langone Medical CenterNew York, New York  10016
Associated Medical Professionals of NY, PLLCOneida, New York  13421
UNC Health Care, NC Cancer HospitalChapel Hill, North Carolina  27514
Hoxworth Blood CenterCincinnati, Ohio  45219
OHSU Knight Cancer Institute Hematology OncologyBeaverton, Oregon  97006