Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Evidence of dose limiting Toxicities (DLT) [ Time Frame: First four weeks ] [ Designated as safety issue: Yes ]Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.
- Tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||July 2015|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (PDT)
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670397
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Hassan Arshad, MD||Roswell Park Cancer Institute|