Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer. PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx. Secondary To determine response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of laser light therapy. Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

Official Title
-----------------
Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: HPPH
* Procedure: laser therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Biopsy-confirmed diagnosis of 1 of the following: Mild to severe dysplasia of the larynx Dysplastic lesions > 3 mm in thickness Squamous cell carcinoma in situ of the larynx T1 squamous cell carcinoma of the larynx Tumor > 3 mm in thickness No T2-T4 squamous cell carcinoma of the larynx Newly diagnosed or recurrent disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 Total bilirubin > 2.0 mg/dL Creatinine > 2.0 mg/dL SGOT > 3 times upper limit of normal (ULN) Alkaline phosphatase > 3 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment No porphyria No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Any prior therapy allowed At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment. | Drug: HPPH<br>* Given IV<br>Procedure: laser therapy<br>* Escalating light doses with 665 nm light<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 6 weeks | 
| Tumor response |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer