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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00082719

First received: May 14, 2004

Last updated: April 2, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 14, 2004

Last Updated Date

April 2, 2013

Start Date ^ICMJE

December 2003

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Expression 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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Bladder Cancer
Urethral Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00082719

Other Study ID Numbers ^ICMJE

ID03-0172, P50CA091846, P30CA016672, MDA-ID-030172, CDR0000355831

Has Data Monitoring Committee

Yes

Responsible Party

M.D. Anderson Cancer Center

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Ashish M. Kamat, MD

M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

April 2013

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

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