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

Stopped early · Phase 2

Conditions studied: Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT01353222

Run by

Dendreon

People needed

142

Starts

2011-06-01

Expected to finish

2015-07-01

Last updated by the study team

2017-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• City of Hope Medical Center — Duarte, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Genesis Research — San Diego, California, United States
• Stanford University Hospital — Stanford, California, United States
• University of Colorado, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Neag Comprehensive Cancer Center/University of Connecticut Health Center — Farmington, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Urological Research Network — Hialeah, Florida, United States
• University of Miami Cancer Center — Miami, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
• Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital — Atlanta, Georgia, United States
• American Red Cross — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Kansas City Urology Care — Overland Park, Kansas, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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