Prostate Cancer Clinical Trial - Cell Genesys


		Trials Open for Enrollment
		GVAX® Prostate G-0034
		CG0070 Bladder V-0046

Trial Name:	A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure.
Trial #:	V-0046

Objectives
•	Safety and determination of a maximum tolerated dose (MTD)
•	Clinical response and recurrence-free survival

Key Eligibility Criteria
•	Residual transitional cell carcinoma (TCC) stages Ta, T1, or CIS confirmed by histologic and cystoscopic diagnosis.
•	Failure of at least one prior treatment with intravesical Bacillus Calmette-Guerin (BCG) (primary refactory or recurrent superficial TCC). Failure is defined as evidence of TCC on cystoscopic examination and biopsy or cystoscopic examination and urine cytology at least 6 weeks from last BCG treatment.
•	ECOG performance status of 0-1.

Treatment

Up to 75 patients with superficial bladder cancer (stage Ta, T1, or Carcinoma in situ) following failure of BCG treatment will be enrolled in this Phase 1 study.

Cohorts of three to six patients will be assigned to receive intravesical administration of CG0070 either weekly or every four (4) weeks for up to a total of six (6) doses.

Dose escalation will proceed until the MTD or MFD is established.

Visits will occur for approximately 2 years following treatment, and patients will then be monitored for long-term follow-up.

Enrollment information

Select major eligibility criteria are listed above. For more information, please call
1-800-648-6747, ext. 3210. You may also check clinicaltrials.gov for a current list of participating centers.

Back to Top


	About Us \| Product Progress \| Patient Information \| Investor's Corner \| Career Opportunities
	©2008 Cell Genesys, Inc. \| Site Design: Heiney & Craig, Inc. \| Home \| Search \| Contact Us