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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
laser therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment PDT

Arm Description

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.

Outcomes

Primary Outcome Measures

Toxicity
Tumor response

Secondary Outcome Measures

Full Information

First Posted
May 8, 2008
Last Updated
October 16, 2018
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00675233
Brief Title
Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2008 (Actual)
Primary Completion Date
June 28, 2013 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment PDT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HPPH
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
laser therapy
Intervention Description
Escalating light doses with 665 nm light
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
6 weeks
Title
Tumor response
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Arshad, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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