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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00082719

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 I

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:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferons

U.S. FDA Resources

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 2012 (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:

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.
Patients must understand the investigational nature of this study and provide written, informed consent.

Exclusion Criteria:

Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
Patients with current symptoms suggestive of clinically significant affective disorder.
Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Contacts and Locations

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

National Cancer Institute (NCI)

Investigators

Study Chair:	Colin P. Dinney, MD	M.D. Anderson Cancer Center
Study Chair:	Randall E. Millikan, MD, PhD	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ashish M. Kamat, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00082719 History of Changes
Other Study ID Numbers:	ID03-0172, P50CA091846, P30CA016672, MDA-ID-030172, CDR0000355831
Study First Received:	May 14, 2004
Last Updated:	May 31, 2011
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
Urethral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b

Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 13, 2012