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

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer

Treatments: Procedure: laser therapy; Drug: HPPH

Study type: Interventional

Funder types: Other

Identifiers

NCT00675233

CDR0000595166

I 119207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Treatment PDT

Experimental group

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.

Treatment:

Procedure: laser therapy

Drug: HPPH