NCT00670397

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	HPPH	IV

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-11-01
• Completion: 2015-07-01
• First posted: 2008-05-01
• Last updated: 2016-03-16

Locations

1 site across 1 country: United States