Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer

A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer

This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) 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. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.

PRIMARY OBJECTIVES:

I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.

SECONDARY OBJECTIVES:

I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.

II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.

III. Observe for wound complications.

OUTLINE: This is a dose-escalation study of laser light.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.

After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.

Inclusion Criteria:

• Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
• Female patients must not be pregnant (documented by human chorionic gonadotropin [HCG] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
• No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT

Exclusion Criteria:

• Patients with unresectable tumors
• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
• White blood cell (WBC) < 4,000
• Platelet count < 100,000
• Prothrombin time 1.5 times above the upper normal limit
• Total serum bilirubin > 2.0 mg/d
• Serum creatinine > 2 mg%
• Alkaline phosphatase (hepatic) > 3 times the upper normal limit
• Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
• Patients on concurrent chemotherapy or radiation therapy will be excluded
• Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
• Has not recovered from toxicity of prior therapy