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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00082719
First received: May 14, 2004
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Urethral Cancer
Biological: Recombinant Interferon Alfa
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Data collection continues with treatment in absence of unacceptable toxicity.


Estimated Enrollment: 35
Study Start Date: December 2003
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Interferon Alfa 2b
  • Intron A
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:
  • Interferon Alfa 2b
  • Intron A
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:
  • Interferon Alfa 2b
  • Intron A
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:
  • Interferon Alfa 2b
  • Intron A

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082719

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ashish M. Kamat, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00082719     History of Changes
Other Study ID Numbers: ID03-0172, P50CA091846, P30CA016672, MDA-ID-030172, CDR0000355831, NCI-2012-02015
Study First Received: May 14, 2004
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
localized transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
anterior urethral cancer
posterior urethral cancer
urethral cancer associated with invasive bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014