A RANDOMIZED, PHASE 2, OPEN-LABEL STUDY EVALUATING DN24-02 AS ADJUVANT THERAPY IN SUBJECTS WITH HIGH RISK HER2+ UROTHELIAL CARCINOMA
This study is for patients with HER2+ urothelial cancer. This study will evaluate if giving DN24-02 is effective in treating their urothelial cancer following surgical resection as the primary treatment for curative therapy.
- Must have had surgical resection performed within 42 days (6 weeks) prior to registration on trial. - Must not show evidence of disease (spread of cancer) on CT scan within 14 days of study registration. - Must have HER2/neu tissue expression greater than 1+ read by the study's pathologist. - Last neoadjuvant chemo treatment administered at least 60 days prior to registration. - Adequate liver and kidney function levels on blood work. - No partial cystectomy for bladder cancer as primary tumor. - No adjuvant radiation therapy allowed fro urothelial or prostate cancer following surgical resection.
DN24-02 is an immunotherapy drug made from the individual's own cells. Patients on this trial are randomized to either treatment arm with DN24-02 or Control arm without DN24-02. The DN24-02 drug is given over 60 minutes IV following apheresis at blood bank 3 days prior. A total of 3 infusions are given every 2 weeks for a six week period. Patients are then to return to clinic for follow up as instructed. Control arm patients return at week 10. week 18 and week 24 following screening. Additional follow up appointments will be scheduled for follow up. Patients are re evaluated with CT scan at designated time points per the study.
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