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

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: Bladder Cancer; Urethral Cancer
• Intervention / Treatment: Biological: Recombinant Interferon Alfa

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	Data collection continues with treatment in absence of unacceptable toxicity.	2 Years

Collaborators and Investigators

• 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

Helpful Links

• University of Texas MD Anderson Cancer Center Official Website

Study record dates

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: stage III bladder cancer; stage IV bladder cancer; localized transitional cell cancer of the renal pelvis and ureter; metastatic transitional cell cancer of the renal pelvis and ureter; urethral cancer associated with invasive bladder cancer; regional transitional cell cancer of the renal pelvis and ureter; anterior urethral cancer; posterior urethral cancer; stage II bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urethral Diseases; Urinary Bladder Neoplasms; Urethral Neoplasms; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2
• 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)