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Completed

NCT Number: NCT00453336

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

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Precancerous/Nonmalignant Condition Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Porfimer Sodium

Drug

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

Photodynamic Therapy

Procedure

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

Primary outcomes

  1. 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.

  2. Number of Participants Experiencing Adverse Events

    Time frame: 6 months

    Number of participants enrolled experiencing serious adverse events and/or other non-serious events

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Mar 28, 2007
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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