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

NCT ID: NCT00675233

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-25
• Study Completion Date: 2018-09-27

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

Given IV

laser therapy

Intervention Type: PROCEDURE

Escalating light doses with 665 nm light

Interventions

HPPH

Given IV

Intervention Type: DRUG

laser therapy

Escalating light doses with 665 nm light

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Arshad, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

I 119207

Identifier Type: -

Identifier Source: secondary_id

CDR0000595166

Identifier Type: -

Identifier Source: org_study_id