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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00453336
First received: March 27, 2007
Last updated: July 25, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Precancerous/Nonmalignant Condition
Drug: Porfimer Sodium
Procedure: Photodynamic Therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.

  • Number of Participants Experiencing Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of participants enrolled experiencing serious adverse events and/or other non-serious events


Enrollment: 45
Study Start Date: June 2003
Study Completion Date: May 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Microlens Diffuser P/N 5416

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453336

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Francisco Civantos, Jr., MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00453336     History of Changes
Other Study ID Numbers: UMIAMI-20020618, SCCC-2002103, WIRB-20050715
Study First Received: March 27, 2007
Results First Received: August 14, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
recurrent squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
oral leukoplakia

Additional relevant MeSH terms:
Head and Neck Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
Trioxsalen
Dihematoporphyrin Ether
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014