Completed

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

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What is being tested

Recombinant Interferon Alfa

Biological
Who is being recruted

Urogenital Diseases
+10

+ Urinary Bladder Diseases
+ Urinary Bladder Neoplasms
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 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual 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 14, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Female Urogenital Diseases and Pregnancy Complications
Neoplasms
Neoplasms by Site
Urethral Diseases
Urethral Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Female Urogenital Diseases
Male Urogenital Diseases
Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 disorder. 3. 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.

In all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.
Group II
Experimental
Interferon alfa as in arm I at a higher dose.

In all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.
Group III
Experimental
Interferon alfa SC once daily.

In all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.
Group IV
Experimental
Interferon alfa as in arm III at a higher dose.

In all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.
Study Objectives
Primary Objectives

Data collection continues with treatment in absence of unacceptable toxicity.

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 CenterHouston, United StatesSee the location
CompletedOne Study Center