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

NCT00322699 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-10-26

No results posted yet for this study

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.

Conditions

  • Superficial Bladder Cancer

Interventions

PROCEDURE

Whole bladder laser light treatment as an alternative to radical cystectomy

The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.

DRUG

Photofrin

The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.

Sponsors & Collaborators

  • North Florida Foundation for Research and Education

    collaborator OTHER

  • Axcan Pharma

    collaborator INDUSTRY

  • North Florida/South Georgia Veterans Health System

    lead OTHER

Principal Investigators

  • Unyime O Nseyo, M.D. · NF/SGVAHS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2010-04-30
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322699 on ClinicalTrials.gov