Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

December 14, 2016 updated by: University of Miami

A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium (Photofrin®) for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, precancerous cells and cancer cells are killed.

PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract.
  • Determine the safety of this regimen in these patients.

OUTLINE: Patients are stratified according to disease condition (benign vs malignant).

Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.

After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 116 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Any of the following benign lesions:

      • Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant
      • Carcinoma in situ

    • Superficial (< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx

      • T1-T3 disease

      • Meets one of the following criteria:

        • Failed radiation therapy and refused standard salvage surgery
        • Refused radiation therapy and/or surgery as primary therapy
        • No good surgical alternative with acceptable morbidity

    • Condemned mucosa syndrome

      • At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas

PATIENT CHARACTERISTICS:

  • Creatinine ≤ 2 mg/dL
  • AST and ALT ≤ 30% elevated
  • Alkaline phosphatase ≤ 30% elevated
  • Bilirubin ≤ 1.0 mg/dL
  • No contraindication to anesthesia or analgesia
  • No porphyria
  • No hypersensitivity to porphyrins
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: Porfimer Sodium
Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
Other Names:
  • Photofrin
Procedure: Photodynamic Therapy
Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
Other Names:
  • Microlens Diffuser P/N 5416

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Time Frame: 6 months
Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
6 months
Number of Participants Experiencing Adverse Events
Time Frame: 6 months
Number of participants enrolled experiencing serious adverse events and/or other non-serious events
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Francisco Civantos, Jr., MD, University of Miami Sylvester Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020618
  • SCCC-2002103 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20050715 (Other Identifier: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Porfimer Sodium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe