| Eligibility Criteria |
- Patients must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade
- Patients must be ≥ 18 years of age
- Patients must have Zubrod Performance Status ≤ 2
- Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible
- Patients must have had all visible tumor resected completely within 60 days prior to registration. CIS disease is not expected to be completely excised. All patients must have tumor tissue from the histologic diagnosis of recurrence
- Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration
- Patients must not have had urothelial carcinoma in the prostate or upper urinary tract within the previous 24 months, or muscle invasive urothelial carcinoma of the bladder at any time. Patients must have a CT or MRI of the abdomen and pelvis to rule out upper tract malignancy and intra-abdominal metastases within 90 days prior to registration
- Patients must be BCG-unresponsive. A patient is BCG-unresponsive if they meet one or more of the following criteria:
- Patient has persistent or recurrent high-grade Ta/CIS urothelial carcinoma after completing therapy with at least induction BCG (≥ 5 doses) and first round maintenance or second induction BCG (≥ 2 doses)
- Patient has high grade T1 urothelial carcinoma after induction BCG (≥ 5 doses) only or after induction BCG (≥ 5 doses) and first round maintenance or second induction BCG (≥ 2 doses)
- Patient is disease-free at 6 months after starting BCG (i.e., complete response) but then experiences a high-grade recurrence within 6 months after the last BCG dose
- Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other therapy while on this protocol
- Patients must not have received any prior radiation to the bladder for bladder cancer
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
Please contact Legacy Oncology Research for additional study inclusion/exclusion information. |
