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

University of Miami

Status and phase: Completed; Phase 2

Conditions: Precancerous/Nonmalignant Condition; Head and Neck Cancer

Treatments: Procedure: Photodynamic Therapy; Drug: Porfimer Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00453336

20020618

WIRB-20050715 (Other Identifier)

SCCC-2002103 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: Porfimer Sodium

Procedure: Photodynamic Therapy