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Trial record 1 of 1 for:    NCT01353222
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DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01353222
First received: May 4, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

This study is being conducted to examine survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.


Condition Intervention Phase
Urothelial Carcinoma
Biological: DN24-02
Other: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Evaluate overall survival following administration of DN24-02 [ Time Frame: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate disease-free survival following administration of DN24-02 [ Time Frame: Baseline through disease recurrence or study completion (approximately 5 years), whichever occurs first ] [ Designated as safety issue: No ]
  • Evaluate the safety of DN24-02 [ Time Frame: Baseline through study completion (approximately 5 years) ] [ Designated as safety issue: Yes ]
    Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, cardiac function, and physical examination findings.

  • Evaluate the magnitude of immune response induced by administration of DN24-02 [ Time Frame: Baseline through disease recurrence ] [ Designated as safety issue: No ]
    Subjects will be evaluated for cellular and humoral immune responses to HER2 following periodic blood draws.

  • Evaluate the magnitude of cumulative CD54 upregulation following administration of DN24-02 [ Time Frame: Prior to infusion, approximately 4-8 weeks after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Standard of Care Other: Standard of Care
Standard of care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353222

  Hide Study Locations
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
American Red Cross
Atlanta, Georgia, United States, 30324
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
Atlanta, Georgia, United States, 30322
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
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
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
Weill Cornell Medical College
New York, New York, United States, 10065
Memorial Sloan Kettering
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
Mount Sinai School of Medicine Department of Urology
New York, New York, United States, 10029
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
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
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45219
Jewish Hospital
Cincinnati, Ohio, United States, 45236
TriState Urologic Services PSC, Inc. dba TUG Research
Cincinnati, Ohio, United States, 45212
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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
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
UW Medical Center
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Candice McCoy Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01353222     History of Changes
Other Study ID Numbers: N10-1
Study First Received: May 4, 2011
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
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

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

ClinicalTrials.gov processed this record on November 23, 2014