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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and Stage I Carcinoma of the Oral Cavity

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (PDT)<br>Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light treatment to the tumor bed on day 2. Treatment may repeat every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. | Drug: HPPH<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of dose limiting Toxicities (DLT) | Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT. | First four weeks | 
| Tumor response |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage 0 lip and oral cavity cancer