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

Phase 1TerminatedNCT00670397

Roswell Park Cancer Institute11 enrolled

Overview

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.

OBJECTIVES: Primary * To determine the maximum tolerated dose in the oral cavity of photodynamic therapy (PDT) using HPPH and 665 nm light in patients with recurrent dysplasia, carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity. Secondary * To determine response of dysplasia, carcinoma in situ, and selected patients with T1 squamous cell carcinoma of the oral cavity using PDT with HPPH and 665 nm light. OUTLINE: This is a dose-escalation study of laser light dose therapy. Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours after receiving HPPH, patients undergo laser light treatment to the tumor bed on day 2. Patients with multicentric or large area confluent disease receive a second course of treatment at least 8 weeks later for lesions untreated at the first treatment session. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and periodically thereafter.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

HPPHDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

Evidence of dose limiting Toxicities (DLT)

Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.

Time frame: First four weeks

Tumor response

Time frame: 3 months

Data from ClinicalTrials.gov

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