Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New Haven, Connecticut 06520


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

N10-1


NCT ID:

NCT01353222


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dendreon


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

142


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert Israel, MD
Study Director
Valeant Pharmaceuticals North America LLC

Study Dates

Start Date:June 2011
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:July 2015
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 21, 2016
First Received Date:May 4, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate the magnitude of cumulative CD54 upregulation following administration of DN24-02
Time Frame:Prior to infusion, approximately 4-8 weeks after randomization
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the magnitude of immune response induced by administration of DN24-02
Time Frame:Baseline through disease recurrence
Safety Issues:False
Description:Subjects will be evaluated for cellular and humoral immune responses to HER2 following periodic blood draws.
Outcome Type:Secondary Outcome
Measure:Evaluate the safety of DN24-02
Time Frame:Baseline through study completion (approximately 5 years)
Safety Issues:True
Description:Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, cardiac function, and physical examination findings.
Outcome Type:Secondary Outcome
Measure:Evaluate disease-free survival following administration of DN24-02
Time Frame:Baseline through disease recurrence or study completion (approximately 5 years), whichever occurs fi
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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 completi
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:DN24-02
Description: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.
Arm Name:DN24-02
Intervention Type:Other
Name:Standard of Care
Description:Standard of care
Arm Name:Standard of Care

Study Arms

Study Arm Type:Other
Arm Name:Standard of Care
Study Arm Type:Active Comparator
Arm Name:DN24-02
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Dendreon

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.