Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx

• Histologically confirmed squamous cell carcinoma of the target tumor(s)

• Tumor thickness is 4 mm or less (in the judgment of the physician)

• Computed tomography (CT) of the neck to confirm staging

• Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)

• Life expectancy of at least 12 months in the judgment of the physician

• Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

• Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

• Patients with known brain metastases should be excluded from this clinical trial

• Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds

• White blood cells (WBC) < 4,000

• Total serum bilirubin > 2 mg/dL

• Serum creatinine > 2 mg/dL

• Alkaline phosphatase (hepatic) > 3 times the upper normal limit

• Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Nodal disease as detected by clinical exam or CT

• Pregnant or nursing female patients

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

• Received an investigational agent within 30 days prior to enrollment