Urothelial CarcinomaPhase 2NCT01353222
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
A Phase 2 study testing DN24-02 in people with Urothelial Carcinoma, run by Dendreon at 60 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- DN24-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 60 sitesUnited States
- Study dates
- Jun 2011to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital
Atlanta, Georgia, 30322
American Red Cross
Atlanta, Georgia, 30324
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, 80045
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Johns Hopkins Hospital
Baltimore, Maryland, 21287
OHSU Knight Cancer Institute Hematology Oncology
Beaverton, Oregon, 97006
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Urology Health Specialists, LLC
Bryn Mawr, Pennsylvania, 19010
Roswell Park Cancer Institute
Buffalo, New York, 14263
Lahey Clinic
Burlington, Massachusetts, 01805
UNC Health Care, NC Cancer Hospital
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medical Center
Chicago, Illinois, 60637
TriState Urologic Services PSC, Inc. dba TUG Research
Cincinnati, Ohio, 45212
Hoxworth Blood Center
Cincinnati, Ohio, 45219
Jewish Hospital
Cincinnati, Ohio, 45236
The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology
Columbus, Ohio, 43210, 43221, 43212
The Urology Center of Colorado
Denver, Colorado, 80211
City of Hope Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
Neag Comprehensive Cancer Center/University of Connecticut Health Center
Farmington, Connecticut, 06030
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Urological Research Network
Hialeah, Florida, 33016
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
University of Miami Cancer Center
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Urology Associates, P.C.
Nashville, Tennessee, 37209
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, 10016
Memorial Sloan Kettering
New York, New York, 10021
Mount Sinai School of Medicine Department of Urology
New York, New York, 10029
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Sentara Leigh Hospital
Norfolk, Virginia, 23502
GU Research Center, LLC
Omaha, Nebraska, 68130
Associated Medical Professionals of NY, PLLC
Oneida, New York, 13421
Kansas City Urology Care
Overland Park, Kansas, 66211
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Providence Medical Center
Portland, Oregon, 97213
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Genesis Research
San Diego, California, 92123
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Virginia Mason Medical Center
Seattle, Washington, 98101
UW Medical Center
Seattle, Washington, 98195
Oregon Urology Institute
Springfield, Oregon, 97477
Stanford University Hospital
Stanford, California, 94305
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, 33612
Michigan Institute of Urology
Troy, Michigan, 48084
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, 74146
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: 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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- DN24-02, Standard of Care
- Keywords
- 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
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Neoplasms by Site, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN24-02Biological
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.
Standard of CareOther
Observation only until documentation of disease recurrence.
| Study group | Role | What they receive |
|---|---|---|
| DN24-02 | Experimental | Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions. Receives: Biological: DN24-02 |
| Standard of Care | Other | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from randomization to death due to any cause.
*This study was terminated early due to administrative reasons.
Measured: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Israel, MD, Study director, Valeant Pharmaceuticals North America LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353222
- Sponsor's protocol ID
- N10-1
- Status last verified
- Apr 2017
- First submitted
- 4 May 2011
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT01353222
- Acronym / sponsor ID
- N10-1
- Conditions
- Urothelial Carcinoma
- Keywords
- Bladder cancer, Renal pelvis cancer, Ureteral cancer, Urethral cancer, Bladder, Renal pelvis, Ureter, Urethra
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN24-02 | Experimental | Biological: DN24-02Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions. |
| Standard of Care | Other | Other: Standard of CareSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DN24-02DN24-02 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. | Biological | DN24-02 |
| Standard of CareObservation only until documentation of disease recurrence. | Other | Standard of Care |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Israel, MD study director
Valeant Pharmaceuticals North America LLC
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DN24-02 in people with Urothelial Carcinoma, run by Dendreon at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.