Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium

May 12, 2015 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Low-dose interferon alfa subcutaneously (SC) twice daily.
Biological: Recombinant Interferon Alfa

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.

Other Names:
  • Intron A
  • Interferon Alfa 2b
Experimental: Arm II
Interferon alfa as in arm I at a higher dose.
Biological: Recombinant Interferon Alfa

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.

Other Names:
  • Intron A
  • Interferon Alfa 2b
Experimental: Arm III
Interferon alfa SC once daily.
Biological: Recombinant Interferon Alfa

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.

Other Names:
  • Intron A
  • Interferon Alfa 2b
Experimental: Arm IV
Interferon alfa as in arm III at a higher dose.
Biological: Recombinant Interferon Alfa

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.

Other Names:
  • Intron A
  • Interferon Alfa 2b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon
Time Frame: 2 Years
Data collection continues with treatment in absence of unacceptable toxicity.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ashish M. Kamat, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimate)

May 19, 2004

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID03-0172
  • P30CA016672 (U.S. NIH Grant/Contract)
  • P50CA091846 (U.S. NIH Grant/Contract)
  • MDA-ID-030172 (Other Identifier: UT MD Anderson Cancer Center)
  • CDR0000355831 (Registry Identifier: NCI PDQ)
  • NCI-2012-02015 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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