Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to
 light to kill tumor cells. This may be an effective palliative treatment for head and neck
 cancer.

 PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative
 treatment in patients who have recurrent, refractory, or second primary head and neck cancer
 that cannot be treated with surgery or radiation therapy.
OBJECTIVES: I. Determine the individual clinical benefit of temoporfin-mediated photodynamic
 therapy for palliative treatment in patients with recurrent, refractory, or second primary
 squamous cell cancer of the head and neck. II. Determine the improvement in global,
 functional, and symptomatic measures of quality of life in these patients. III. Determine the
 toxic effects, tolerability, and safety of this regimen in these patients. IV. Determine the
 population pharmacokinetics, objective tumor response (complete and partial), and the 1 year
 survival of these patients on this regimen.

 OUTLINE: This is a multicenter study. Patients receive IV temoporfin on day -4, followed by
 laser light therapy on day 0. Patients are treated every 4 to 16 weeks for a maximum of 3
 courses. Patients are evaluated on days 1, 2, 7, and weeks 2, 4, 6, 8, 12, and 16 following
 laser light therapy. Quality of life is assessed at baseline through week 12 of follow-up.
 Patients are followed monthly for 4 months after the final treatment, then every 3 months for
 1 year.

 PROJECTED ACCRUAL: A minimum of 50 prospective and 25 retrospective patients will be accrued
 for this study.
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, refractory, or second primary
 squamous cell cancer of the head and neck that is incurable with surgery or radiotherapy
 Any N, Any M, single or multiple tumor(s) Locally accessible, discrete tumor(s) by CT or
 MRI scan Must be considered incurable with surgery or radiotherapy, for example: Distant
 disease (e.g., lung and/or liver metastases) OR Cervical disease fixed to surrounding
 structures (e.g., carotid artery or prevertebral fascia) OR Metastases in the site of prior
 radiotherapy OR Not suitable for anesthesia or reconstructive surgery OR Multiple cutaneous
 metastases

 PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life
 expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
 specified Other: No disease exacerbated by light, including systemic lupus erythematosus,
 psoriasis, porphyria, actinic reticuloid, or xeroderma pigmentosum Not pregnant or nursing
 Negative pregnancy test Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days
 since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Concurrent steroid
 therapy allowed Radiotherapy: At least 30 days since prior radiotherapy to the head and
 neck Surgery: At least 30 days since prior surgery and recovered Other: At least 30 days
 since prior light activated therapy or medication (e.g.,PUVA or Accutane) No prior
 photodynamic therapy At least 30 days since prior experimental drugs