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

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ClinicalTrials.gov Identifier: NCT00675233
Recruitment Status : Active, not recruiting
First Posted : May 9, 2008
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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 T1 Carcinoma of the Larynx
Actual Study Start Date : April 25, 2008
Actual Primary Completion Date : June 28, 2013
Estimated Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Toxicity [ Time Frame: 6 weeks ]
  2. Tumor response [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT00675233


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
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00675233     History of Changes
Other Study ID Numbers: CDR0000595166
I 119207
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms