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

Condition(s) targeted: Superficial Bladder Cancer

Intervention: Photofrin mediated-Whole Bladder Photodynamic Therapy (Procedure)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: North Florida/South Georgia Veterans Health System

Official(s) and/or principal investigator(s):
Unyime O Nseyo, M.D., Principal Investigator, Affiliation: NF/SGVAHS

Overall contact:
Unyime O Nseyo, M.D., Phone: (352)3761611, Ext: 6468, Email: Unyime.Nseyo2@med.va.gov

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.

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

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dose Limiting Toxicity

Secondary outcome: Disease progression

Detailed description: Patient Evaluation and Treatment:

1. Patients will sign an IRB-approved informed consent form

2. Initial patient assessments will include:

- eligibility

- History and physical.

- clinical profile

- upper urinary tract imaging (if clinically indicated)

- urinary symptoms assessment

WBPDT Treatment:

1. Porfimer Sodium (Photofrin) 1. 5 mg/kg iv followed 2 days later by whole bladder laser light at 630 nm with target light doses of 1200 Joules (+/-100Joules)

2. Patients will undergo three sequential WBPDT treatments

3. Treatments will occur at least three months apart

4. All WBPDT treatments will occur within 12 months

Decisions to administer a second or third WBPDT will be based upon urological and medical assessment of the individual patient and not necessarily dependent upon Dose Limiting Toxicities (DLT) or early stopping endpoints (although such information may be taken into account in the individual patient assessment). Patients experiencing DLT may continue WBPDT at the investigator's discretion at the same or reduced doses of Porfimer Sodium and/or light.

The following will be considered Dose Limiting Toxicities (DLT):

- Urinary symptoms grade 3, or more over 12 weeks duration (see section 7 for

toxicity grading)

- Loss of > 50% of baseline bladder volume

- Clinical decision of investigator or patient to discontinue due to toxicity.

Efficacy will be assessed on the basis of the following criteria:

- Complete Response: cystoscopy with biopsy and/or cytology without evidence of

cancer.

- Partial Response: normal cystoscopy and biopsies, if obtained, but persistent

positive or suspicious cytology localized to the bladder; or, for patients with CIS, > 50% reduction in extent of CIS.

- Persistent/Recurrent Disease: persistent or recurrent cancer of the same or lesser

stage and grade as at enrollment without obvious increase in tumor burden.

- Progression: cancer of any greater stage or grade than at enrollment or obvious

increase in tumor burden.

Referred patients will undergo post-PDT cystoscopy by the referring Urologists, who will transmit the results to the study site in Gainesville,Fl.

5. Symptoms will be assessed for one month following each WBPDT by weekly telephone contact.

6. Urine and blood for cytokines will be obtained before each treatment and possibly

twice afterwards and stored - 80oF for analysis later.

7. Biopsy specimen samples from tumor and normal bladder may be obtained at cystoscopy and stored for later analysis for biomarkers.

8. Patients will be followed for toxicity, disease status, urinary tract symptoms, and survival.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Unyime O Nseyo, M.D., Phone: (352)3761611, Ext: 6468, Email: Unyime.Nseyo2@med.va.gov

Malcom Randall NF/SG Veterans Administration Health System, Gainesville, Florida 32608, United States; Recruiting
Unyime O Nseyo, M.D., Phone: 352-376-1611, Ext: 6468, Email: Unyime.Nseyo2@med.va.gov
Maria-Carmenza Mejia, Phone: (352)3761611, Ext: 6952, Email: Maria.Mejia@va.gov

Starting date: February 2005
Last updated: August 21, 2009