Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

October 16, 2018 updated by: Roswell Park Cancer Institute

Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.

Secondary

  • To determine response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of laser light therapy.

Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Biopsy-confirmed diagnosis of 1 of the following:

    • Mild to severe dysplasia of the larynx

      • Dysplastic lesions > 3 mm in thickness
    • Squamous cell carcinoma in situ of the larynx

    • T1 squamous cell carcinoma of the larynx

      • Tumor > 3 mm in thickness
      • No T2-T4 squamous cell carcinoma of the larynx
  • Newly diagnosed or recurrent disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Total bilirubin > 2.0 mg/dL
  • Creatinine > 2.0 mg/dL
  • SGOT > 3 times upper limit of normal (ULN)
  • Alkaline phosphatase > 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
  • No porphyria
  • No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

  • Any prior therapy allowed
  • At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment PDT
Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment.
Drug: HPPH
Given IV
Procedure: laser therapy
Escalating light doses with 665 nm light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response
Time Frame: 3 months
3 months
Toxicity
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2008

Primary Completion (ACTUAL)

June 28, 2013

Study Completion (ACTUAL)

September 27, 2018

Study Registration Dates

First Submitted

May 8, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (ESTIMATE)

May 9, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000595166
  • I 119207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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