Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage I oral cavity cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute

Criteria

DISEASE CHARACTERISTICS:

• Biopsy-confirmed diagnosis of 1 of the following:

• Mild to severe dysplasia

• Carcinoma in situ (CIS) of the oral cavity

• Carcinoma must be less than 3mm thick

• Stage I (T1) squamous cell carcinoma of the oral cavity

• Recurrent or primary disease

• No T2 or greater squamous cell carcinoma, exophytic CIS, or dysplasia lesions

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Total bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 2.0 mg/dL

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

• SGOT ≤ 3 times ULN

• Not pregnant

• Fertile patients must use effective contraception

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

PRIOR CONCURRENT THERAPY:

• Prior therapy of any type allowed

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