Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is evaluating efficacy and toxicity of three sequential whole bladder photodynamic treatment with Photofrin and red laser light (630 nm) in the management of superficial bladder cancer (non-muscle invasive) in those patients who have failed or are not candidates for conventional intravesical therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Florida/South Georgia Veterans Health System
• Collaborators: Axcan Pharma; North Florida Foundation for Research and Education
• Treatments: Dihematoporphyrin Ether; Hematoporphyrin Derivative; Trioxsalen

Criteria

Inclusion Criteria:

• Pathological diagnosis of bladder cancer, non muscle invasive

• Recurrent after at least one course of standard intravesical therapy after transurethral resection (TURBT).

• Maximum debulking of tumor by TURBT/fulguration

• One or more of the following:

• Contraindications to conventional intravesical therapy, including patient's refusal.

• Positive or suspicious urine cytology localized to the bladder

• Prior intravesical therapy and persistent atypia.

• Premalignant (diffuse squamous metaplasia or malakoplakia) lesions.

• Bladder capacity greater or equal to 150 cc.

• No contraindications to an appropriate anesthesia or analgesia.

• Karnofsky's performance status > 50.

• Patients must sign an informed consent form in accordance with the Institution's Review Board and FDA 21 CFR Part 50.

• Female patients must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.

Exclusion Criteria:

• Pregnant or nursing mother.

• Known hypersensitivity to porphyrins.