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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670397

Enrollment

Registered

2008-05-01

Start date

2010-06-30

Completion date

2015-07-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage 0 lip and oral cavity cancer

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.

Interventions

DRUGHPPH

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evidence of dose limiting Toxicities (DLT)	First four weeks	Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.
Tumor response	3 months	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026