MDACC Study Summary ID03-0172

Study Summary
No. ID03-0172:.......Bladder......Ashish M. Kamat......Urology

Study Summary Title



Study Summary Number:	ID03-0172

Study Title:	Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon

Physician

New Patient Referral



Name:	Ashish M. Kamat	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Bladder	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	No additional visits required by the protocol, other than those dictated by the treatment of their cancer.

Treatment Agents:	Interferon Alpha-2B	Home Care:	The interferon could be self-administered or administered in the Urology Clinic. Tylenol 650mg by mouth 30 minutes prior to injection and every 4 hours as necessary.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	one visit, 23 hour observation


Description/ Intervention:	The goal of this clinical research study is to learn what effects (if any) interferon has on bladder cancer tissue.

Study Objectives / Outcomes

To obtain descriptive data on the modulation of apoptosis related pathways in urothelial cancers induced by short-term exposure to low-dose interferon.

Study Status Information



Study Activation / Registration Date:	12/03/2003

IRB Review and Approval Date:	04/16/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

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

Exclusion Criteria:

1) Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.

2) Patients with current symptoms suggestive of clinically significant affective disorder.

3) Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Links

Registration Number: NCT00082719
Study Information on Clinical Trials Registry (clinicaltrials.gov)