A Multicenter, Multi-National, Open-Label, Single Group, Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy (PDT) for the Palliative Treatment of Recurrent, Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy

Inclusion Criteria

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