Completed

Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon

What is being tested

Recombinant Interferon Alfa

Biological

Who is being recruted

Urogenital Diseases+10

+ Urinary Bladder Diseases

+ Urinary Bladder Neoplasms

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: December 2003

See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

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.

Official TitleModulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon

NCT00082719

Principal SponsorM.D. Anderson Cancer Center

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

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

Urogenital DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by SiteUrethral DiseasesUrethral NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

2 inclusion criteria required to participate

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.

Patients must understand the investigational nature of this study and provide written, informed consent.

3 exclusion criteria prevent from participating

Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.

Patients with current symptoms suggestive of clinically significant affective disorder.

Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Low-dose interferon alfa subcutaneously (SC) twice daily.

Group II

Experimental

Interferon alfa as in arm I at a higher dose.

Group III

Experimental

Interferon alfa SC once daily.

Group IV

Experimental

Interferon alfa as in arm III at a higher dose.

Study 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

Suspended

University of Texas MD Anderson Cancer Center

Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps

CompletedOne Study Center