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

This study has been terminated.
(safety issues)
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: April 30, 2008
Last updated: March 14, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Head and Neck Cancer
Drug: HPPH
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Evidence of dose limiting Toxicities (DLT) [ Time Frame: First four weeks ]
    Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.

  • Tumor response [ Time Frame: 3 months ]

Enrollment: 11
Study Start Date: June 2010
Study Completion Date: July 2015
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: HPPH

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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 therapy of any type allowed
  • More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00670397

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Hassan Arshad, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00670397     History of Changes
Other Study ID Numbers: I 109307
RPCI-I-109307 ( Other Identifier: Roswell Park Cancer Institute )
Study First Received: April 30, 2008
Last Updated: March 14, 2016

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma in Situ
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases processed this record on May 23, 2017