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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453336
• Other study ID #: UMIAMI-20020618
• Secondary ID: SCCC-2002103WIRB
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: July 25, 2014
• Start date: June 2003
• Est. completion date: May 2010

Study information

• Verified date: October 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Precancerous Conditions
• Precancerous/Nonmalignant Condition

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Civantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment	Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.	6 months	No
Primary	Number of Participants Experiencing Adverse Events	Number of participants enrolled experiencing serious adverse events and/or other non-serious events	6 months	Yes