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

Tracking Information

First Received Date ^ICMJE

May 14, 2004

Last Updated Date

February 6, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00082719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Modulation of Death Effector Espression By Short-Term Exposure to Low-Dose Interferon

Brief Summary

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer

Intervention ^ICMJE

Biological: recombinant interferon alfa

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00082719

Responsible Party

Study ID Numbers ^ICMJE

CDR0000355831, MDA-ID-030172

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2007

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