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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00670397
• Other study ID #: I 109307
• Secondary ID: RPCI-I-109307
• Status: Terminated
• Phase: Phase 1
• First received: April 30, 2008
• Last updated: March 14, 2016
• Start date: June 2010
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2015
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Neoplasms

Intervention

Drug:
• HPPH
IV

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Tumor response		3 months	No