NCT00322699

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 26, 2012

Status Verified

August 1, 2011

Enrollment Period

5.2 years

First QC Date

May 4, 2006

Last Update Submit

October 25, 2012

Conditions

Superficial Bladder Cancer

Keywords

Bladder CancerPhotodynamic TherapyPhotofrinPhotosensitizationPhotoradiation

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicity

    18 months

Secondary Outcomes (1)

  • Disease progression

    18 months

Study Arms (1)

A single arm, non-randomized Phase II Study

EXPERIMENTAL

Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.

Procedure: Whole bladder laser light treatment as an alternative to radical cystectomyDrug: Photofrin

Interventions

Whole bladder laser light treatment as an alternative to radical cystectomyPROCEDURE

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.

A single arm, non-randomized Phase II Study
PhotofrinDRUG

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.

Also known as: Porfimer Sodium, Photofrin,photosensiter,dye
A single arm, non-randomized Phase II Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or nursing mother.
  • Known hypersensitivity to porphyrins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malcom Randall NF/SG Veterans Administration Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsPhotosensitivity Disorders

Interventions

Dihematoporphyrin Ether

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological Factors

Study Officials

  • Unyime O Nseyo, M.D.

    NF/SGVAHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHYSICIAN

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

February 1, 2005

Primary Completion

April 1, 2010

Study Completion

March 1, 2011

Last Updated

October 26, 2012

Record last verified: 2011-08

Locations

US(1)