Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy

Date de début de l'étude : 1 octobre 2003

Inclusion Criteria: * Patients must have a histologically documented bladder cancer including: transitional cell carcinoma, adenocarcinoma, or squamous cell carcinoma including carcinoma in situ (CIS) requiring cystectomy as a standard therapy for his/her tumor stage and be scheduled for this surgical procedure; patients should not be candidates for neoadjuvant chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Estimated life expectancy 6 or more months * Prior therapy with intravesical Bacille Calmette-Guerin (BCG) and/or chemotherapy is allowed; patient must be at least 2 months beyond the instillation of any prior intravesical agent; patients should not have received systemic chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination and have recovered from all acute toxicities of previous treatment; patients who have received neoadjuvant chemotherapy or radiation therapy to the bladder will be ineligible for this study * Serum creatinine \< 1.5 mg/dl or a creatinine clearance \> 60 ml/min * Bilirubin \< 2.0 mg/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 x normal range * Absolute neutrophil count (ANC) \> 1500/mm\^3 * Platelets \> 75000/mm\^3 * Patients must not have known immunodeficiency disorder (acquired immunodeficiency syndrome \[AIDS\], severe combined immunodeficiency \[SCID\], Wiskott-Aldrich syndrome, etc.); study candidates will not be specifically screened for these, unless clinically indicated; if indicated, the referring physician will do the evaluation * No active/uncontrolled infections * Pregnant women or nursing mothers are ineligible; women with reproductive potential must have negative pregnancy test and are prohibited from sexual intercourse during this study (while receiving vaccine and at least 1 month following last dose); sexual abstinence (as opposed to contraception only) is necessary; similarly, male patients also must avoid sex for the same period as above * No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient's tolerance of the study treatment * Patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who cannot provide informed consent will not be eligible for the study Exclusion Criteria: * Altered immune-competence: * Current or imminent steroid therapy or active antibiotic therapy (antibiotics given for prophylaxis are allowed) * Immune deficiency disease or immunosuppressive therapy in the patient * Present or history of an autoimmune disease in the patient (e.g. autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin) * History of allergy to eggs as this vaccine is manufactured in chicken embryo cells * Patients with any presence of liver function abnormalities, exposure to toxins, ongoing alcohol consumption, history of liver disease and/or history of hepatitis that may suggest persistent disease * Any concurrent active second malignancy or any malignant tumor within the prior 5 years with the exception of a superficial squamous or basal cell skin carcinoma or in situ carcinoma of the cervix or prostate * Pregnancy * Patients with active ischemic heart disease (i.e. class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrhythmias or other arrhythmias requiring therapy