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Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study


OBJECTIVES:

- To determine the response of patients with recurrent dysplasia, squamous cell carcinoma
in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated
with photodynamic therapy using porfimer sodium.

- To identify the local toxicity of this treatment in these patients.

OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy
(PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of
dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of
disease may receive another dose of laser light on day 5 without additional porfimer sodium.
Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the
initial treatment.

After completion of study therapy, patients are followed for 1-2 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy confirmed oral cavity or larynx lesion with mild-to-severe dysplasia OR in
situ or stage I (T1, N0) squamous cell carcinoma of the oral cavity or larynx

- Recurrent disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- WBC ≥ 4,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin ≤ 2.0 mg/dL

- Creatinine ≤ 2.0 mg/dL

- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

- SGOT ≤ 3 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must practice effective contraception

- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

- Any type of prior therapy allowed

- More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nestor R. Rigual, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000564841

NCT ID:

NCT00530088

Start Date:

February 2003

Completion Date:

October 2010

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage 0 laryngeal cancer
  • stage 0 lip and oral cavity cancer
  • Carcinoma
  • Head and Neck Neoplasms
  • Mouth Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263