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

This study has been terminated.
(Administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01353222
First received: May 4, 2011
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • 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.



Enrollment: 142
Study Start Date: June 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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

  Show 60 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
  More Information

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01353222     History of Changes
Other Study ID Numbers: N10-1
Study First Received: May 4, 2011
Results First Received: March 8, 2017
Last Updated: April 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 21, 2017