Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma Which Has Recurred After Initial Intravesical BCG Treatment
1. Patients with either superficial papillary transitional cell carcinoma of the bladder
which has recurred after complete resection and treatment with at least one 6-week
course of BCG. Patients may also have received other treatment for bladder cancer,
e.g., thiotepa, doxorubicin, epirubicin, valrubicin, or mitomycin C).
OR Patients with carcinoma in situ of the bladder which responded completely to BCG
Diagnosis needs to be confirmed by biopsy prior to the start of the study.
2. Males or females more than 18 years old
3. Patients may have had no more than one prior recurrence, i.e., this is the second or
third occurrence of the tumor. There is no minimum or maximum time from prior
occurrence of TCC to the recurrence at entry to this study.
4. Stage at study entry: Patients entered into this study are to be patients for whom
BCG is clinically indicated:
1. Ta excluding TaG1
2. T1, any grade
3. Carcinoma in situ (CIS)
5. All papillary tumors must be resected within 4 weeks prior to the start of study
6. ECOG performance status 2 or less.
7. 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
8. 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
9. If fertile and sexually active, must use adequate contraception
10. Must be able to comply with protocol requirements, including attendance at required
11. Patients must provide written informed consent.
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
3. Patients who have received cytotoxic drugs, systemic corticosteroids or any
investigational drug for any indication within 4 weeks of the start of protocol
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.