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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

May 14, 2004
April 3, 2014
December 2003
March 2016   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00082719 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Urethral Cancer
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 I
    Low-dose interferon alfa subcutaneously (SC) twice daily.
    Intervention: Biological: Recombinant Interferon Alfa
  • Experimental: Arm II
    Interferon alfa as in arm I at a higher dose.
    Intervention: Biological: Recombinant Interferon Alfa
  • Experimental: Arm III
    Interferon alfa SC once daily.
    Intervention: Biological: Recombinant Interferon Alfa
  • Experimental: Arm IV
    Interferon alfa as in arm III at a higher dose.
    Intervention: Biological: Recombinant Interferon Alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Not Provided
March 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082719
ID03-0172, P50CA091846, P30CA016672, MDA-ID-030172, CDR0000355831, NCI-2012-02015
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ashish M. Kamat, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP