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

NCT ID: NCT00670397

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

IV

Interventions

HPPH

IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Arshad, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-109307

Identifier Type: OTHER

Identifier Source: secondary_id

I 109307

Identifier Type: -

Identifier Source: org_study_id