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
18 Years
N/A
Both
Head and Neck Cancer
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 |
