We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00670397
Recruitment Status : Terminated (safety issues)
First Posted : May 1, 2008
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: HPPH Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2010
Primary Completion Date : November 2011
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
IV


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Tumor response [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670397


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

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00670397     History of Changes
Other Study ID Numbers: I 109307
RPCI-I-109307 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 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:
Carcinoma
Head and Neck Neoplasms
Carcinoma in Situ
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases