Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
Recombinant Interferon Alfa
Urogenital Diseases+10
+ Urinary Bladder Diseases
+ Urinary Bladder Neoplasms
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: * 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas MD Anderson Cancer Center
Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps