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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Precancerous/Nonmalignant Condition

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall clinical response rate (complete and partial response) at 3 and 4 months after completion of study treatment

Outcome Time Frame:

3 and 4 months after completion of study treatment

Safety Issue:

No

Principal Investigator

Francisco Civantos, Jr., MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20020618

NCT ID:

NCT00453336

Start Date:

June 2003

Completion Date:

April 2014

Related Keywords:

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

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136