RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth
of urothelial cancer.
PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works
in treating patients with cancer of the urothelium.
- Determine the modulation of apoptosis-related pathways in patients with cancer of the
urothelium treated with short-term low-dose interferon alfa.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment begins at the time of the pre-operative visit and continues until the
time of cystoscopy.
- Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.
- Arm II: Patients receive interferon alfa as in arm I at a higher dose.
- Arm III: Patients receive interferon alfa SC once daily.
- Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms,
treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
1. Patients must have histologically proven urothelial cancer, known or suspected (e.g.
by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and
transurethral biopsy as part of their routine evaluation at M. D. Anderson.
2. Patients must understand the investigational nature of this study and provide
written, informed consent.
1. Patients who are pregnant or lactating are not eligible. Women of child-bearing
potential must have a negative pregnancy test before starting therapy.
2. Patients with current symptoms suggestive of clinically significant affective
3. Patients taking more than physiologic replacement doses of corticosteroids are not