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

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

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, 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 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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