MDACC Study Summary 2004-0495 (Archived)

Study Summary
No. 2004-0495:.......Bladder......Barton Grossman......Urology

Study Summary Title



Study Summary Number:	2004-0495

Study Title:	A Randomized, Comparative, Controlled Phase III Multicenter Study Of Hexvix Fluorescence Cystoscopy And White Light Cystoscopy In The Detection Of Papillary Bladder Cancer And The Early Recurrence Rate In Patients With Bladder Cancer

Physician

New Patient Referral



Name:	Barton Grossman	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 III	Return Visit:	Patients will have a screening evaluation followed by cystoscopy/TURB and 3 follow up cystoscopic examinations three, six and nine months after the initial cystoscopy/TURB.

Treatment Agents:	Hexvix	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patients will stay 23 hours or less at the time of cystoscopy. Some patients may be discharged the same day.

Description/
Intervention:

The goal of this clinical research study is to see if the new drug Hexyl
5-aminolevulinate can help doctors to find bladder cancers more easily, which
may allow them to give a more appropriate treatment. Researchers will study
whether this way to find bladder cancer will lower the chances of the cancer
coming back 3, 6, and 9 months after the tumor has been removed. The safety of
this new drug will also be studied.

Study Objectives / Outcomes

Co-Primary Objectives:

· To compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer.

· To compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Secondary Objectives:

· Comparison of detection rate of histologically confirmed bladder lesions of Hexvix cystoscopy and white light cystoscopy.

· Comparison of the proportion of false positive lesions of Hexvix cystoscopy and white light cystoscopy.

· Evaluation of the clinical usefulness of Hexvix cystoscopy compared to standard cystoscopy.

Evaluation of the safety of Hexvix in patients with bladder cancer.

Study Status Information



Study Activation / Registration Date:	12/09/2004

IRB Review and Approval Date:	09/01/2004

Study Type:	Not Applicable

Recruitment Status:	Terminated

Projected Accrual:	560

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) Male or female, aged 18 years or above, who has given written informed consent.

2) For the first five patients with centers with limited or no experience with Hexvix: patients with an indication for a cystoscopic examination for bladder cancer.

3) Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.

4) Patients having recurrence within 12 months confirmed on an outpatient cystoscopy

5) Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy

Exclusion Criteria:

1) Patients with known tumors in the prostatic urethra or distal urethra

2) Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).

3) Patient with porphyria.

4) Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

5) Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.

6) Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).

7) Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.

8) Conditions associated with a risk of poor protocol compliance.

Links

Registration Number: NCT00209157
Study Information on Clinical Trials Registry (clinicaltrials.gov)