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

NCT ID: NCT00453336

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-05-31

Brief 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.

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.

Conditions

Head and Neck Cancer; Precancerous/Nonmalignant Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

Porfimer Sodium

Intervention Type: 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.

Photodynamic Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Photofrin; Microlens Diffuser P/N 5416

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Civantos, Jr., MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

References

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. doi: 10.6004/jnccn.2012.0179.

Reference Type: RESULT

PMID: 23055220 (View on PubMed)

Other Identifiers

SCCC-2002103

Identifier Type: OTHER

Identifier Source: secondary_id

WIRB-20050715

Identifier Type: OTHER

Identifier Source: secondary_id

20020618

Identifier Type: -

Identifier Source: org_study_id