Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Exclusion Criteria

• •1. Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery.
• •2. Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.
• •3. Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment.
• •4. Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment.
• •5. Patients who have received radiation therapy for bladder cancer at any time or for any condition within 4 months prior to the start of protocol treatment.
• •6. Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy.
• •7. Patients who are receiving coumadin.
• •8. Patients who have had to discontinue a past course of BCG due to toxicity.
• •9. Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations.
• •10. Patients who are known to be HIV positive.
• •11. Females who are pregnant or breast feeding.
• •12. Presence of any medical, psychological or social condition or situation which may, in the investigator's opinion, make it difficult for the patient to tolerate study medication or comply with study procedures and other requirements. This includes but is not limited to active infections, poorly controlled diabetes, uncontrolled cardiac arrhythmias, angina pectoris, or hypertension.
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