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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

May 4, 2011
January 20, 2014
June 2011
June 2016   (final data collection date for 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 completion (approximately 5 years) ] [ Designated as safety issue: No ]
Evaluate overall survival following administration of DN24-02 [ Time Frame: From baseline through the remainder of their lives or until study completion (approximately 5 years) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01353222 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Baseline up to approximately 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urothelial Carcinoma
  • 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.
  • Other: Standard of Care
    Standard of care
  • 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.
    Intervention: Biological: DN24-02
  • Standard of Care
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
Not Provided
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01353222
N10-1
Yes
Dendreon
Dendreon
Not Provided
Study Chair: Candice McCoy Dendreon
Dendreon
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP