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

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

• Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
• Recurrence after treatment with BC-819/PEI and BCG
• Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
• After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Inclusion Criteria:

1. Patients with superficial papillary transitional cell carcinoma of the bladder for whom BCG is clinically indicated. If CIS is present, diagnosis needs to be confirmed by biopsy prior to the start of the study.

2. Males or females more than 18 years old

3. All papillary tumors must be resected within 8 weeks prior to the start of study therapy.

4. ECOG performance status 2 or less.

5. Adequate hematologic function, as demonstrated by

   1. Hemoglobin 10 g/dL or higher
   2. ANC 1.5 x 109/L or higher
   3. Platelets higher than 100 x 109/L

6. Adequate liver and renal function as demonstrated by

   1. AST and ALT each 3.0 x ULN or less
   2. Total bilirubin 1.5 x ULN or less
   3. Creatinine 1.5 X ULN OR less, creatinine clearance >60 mL/min

7. If fertile and sexually active, must use adequate contraception

8. Must be able to comply with protocol requirements, including attendance at required clinic visits.

9. Patients must provide written informed consent.

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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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