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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), October 2007

First Received: May 14, 2004 Last Updated: February 6, 2009 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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 Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Biological: recombinant interferon alfa	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Modulation of Death Effector Espression 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-n1 Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	December 2003

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

DISEASE CHARACTERISTICS:

Histologically confirmed cancer of the urothelium
- Muscle-invasive (known or suspected)
Scheduled for cystoscopy and transurethral biopsy

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No current symptoms suggesting a clinically significant affective disorder
Not pregnant or nursing
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No concurrent corticosteriods except physiologic replacement doses

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Other

More than 6 months since prior antidepressant or mood-altering pharmacologic interventions

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	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Colin P. Dinney, MD	M.D. Anderson Cancer Center
Investigator:	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

No publications provided

Study ID Numbers:	CDR0000355831, MDA-ID-030172
Study First Received:	May 14, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00082719 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Growth Inhibitors

Angiogenesis Modulating Agents
Kidney Diseases
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Urinary Bladder Diseases
Interferons
Urinary Bladder Neoplasms
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Urethral Neoplasms
Interferon Alfa-2a

ClinicalTrials.gov processed this record on November 05, 2009