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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675233
• Other study ID #: CDR0000595166
• Secondary ID: I 119207
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2008
• Est. completion date: September 27, 2018

Study information

• Verified date: October 2018
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 27, 2018
• Est. primary completion date: June 28, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• HPPH
Given IV

Procedure:
• laser therapy
Escalating light doses with 665 nm light

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		6 weeks
Primary	Tumor response		3 months