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Phase I Randomized Study of Short-Term Low-Dose Interferon alfa in Patients With Cancer of the Urothelium

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Treatment Active Not specified NCI MDA-ID-030172
NCT00082719

Special Category: SPORE trial

Objectives

Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa.

Entry Criteria

Disease Characteristics:

Histologically confirmed cancer of the urothelium
- Muscle-invasive (known or suspected)

Scheduled for cystoscopy and transurethral biopsy

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

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

Expected Enrollment

Approximately 30 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Colin Dinney, MD, Protocol chair
Ph: 713-792-3250; 800-392-1611
Randall Millikan, MD, PhD, Protocol co-chair
Ph: 713-563-7245; 800-392-1611
Email: rmillika@mdanderson.org

Trial Sites

U.S.A.

Texas

Houston

M. D. Anderson Cancer Center at University of Texas

Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245

Registry Information

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

Trial Start Date		2003-12-03

Registered in ClinicalTrials.gov		NCT00082719

Date Submitted to PDQ		2003-10-24

Information Last Verified		2007-10-15

NCI Grant/Contract Number		CA16672, CA91846

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.