DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

April 21, 2017 updated by: Dendreon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • San Diego, California, United States, 92123
        • Genesis Research
      • Stanford, California, United States, 94305
        • Stanford University Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Cancer Pavilion
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Neag Comprehensive Cancer Center/University of Connecticut Health Center
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Hialeah, Florida, United States, 33016
        • Urological Research Network
      • Miami, Florida, United States, 33136
        • University of Miami Cancer Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
      • Atlanta, Georgia, United States, 30324
        • American Red Cross
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Urology Care
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GU Research Center, LLC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center, Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center, NYU Langone Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Department of Urology
      • Oneida, New York, United States, 13421
        • Associated Medical Professionals of NY, PLLC
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of New York, PLLC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Health Care, NC Cancer Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Jewish Hospital
      • Cincinnati, Ohio, United States, 45219
        • Hoxworth Blood Center
      • Cincinnati, Ohio, United States, 45212
        • TriState Urologic Services PSC, Inc. dba TUG Research
      • Columbus, Ohio, United States, 43210, 43221, 43212
        • The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Urologic Specialists of Oklahoma
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • OHSU Knight Cancer Institute Hematology Oncology
      • Portland, Oregon, United States, 97213
        • Providence Medical Center
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Institute
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Urology Health Specialists, LLC
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, P.C.
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Sentara Leigh Hospital
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia, PLLC
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • UW Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: DN24-02
Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.
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, BA7072.
OTHER: 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.
Other: Standard of Care
Observation only until documentation of disease recurrence.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dendreon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N10-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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