Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
Data collection continues with treatment in absence of unacceptable toxicity.
Ashish M. Kamat, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|