Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers

Inclusion Criteria:

* 18 years of age and older, male or female, of all races and ethnicities.
* Prior histologically confirmed advanced squamous cell carcinoma of the head and neck that failed standard therapy (radiation, chemotherapy, surgery).
* Must have a Karnofsky performance status higher than 70%.
* Measurable disease by PET-CT, defined as maximum SUV ≥4 in FDG for the tumor.
* Must have a discrete tumor that is accessible for unrestricted illumination of interstitial photodynamic therapy (I-PDT).
* Deemed unsuitable, by multidisciplinary tumor board, for curative treatment options such as radiotherapy, surgery, chemotherapy or a combination of these modalities. This will include patients who have exceeded the maximum radiation dose and are not candidates for re-irradiation.
* Deemed likely to survive for at least 6 months.
* Able and willing to provide written informed consent to participate in the study.
* If a female of childbearing potential, the subject is willing to take a pregnancy test and practice strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after Temoporfin administration. Women who have had a hysterectomy are exempt from these requirements.
* Must have blood glucose level below 250 (and preferably below 200) before FDG injection, required for PET-CT.
* Willing to remain in a light-avoidance environment for a time period of at least 15 days.
* Laboratory criteria:

  * Hematocrit \>= 33%, hemoglobin \>= 11 g/dl
  * Platelet count \>70.000 per microliter
  * BUN: 7 to 20 mg/dL
  * CO2 (carbon dioxide): 20 to 29 mmol/L
  * Creatinine: 0.8 to 1.4 mg/dL
  * Glucose: 64 to 128 mg/dL
  * Serum chloride: 101 to 111 mmol/L
  * Serum potassium: 3.7 to 5.2 mEq/L
  * Serum sodium: 136 to 144 mEq/L
  * Liver function test: albumin, bilirrubin (direct/conjugated), ALT (alanine transaminase), AST (aspartate transaminade), GGT (gamma glutamyl transferase), ALP (alkaline phosphatase) within normal limits
  * White blood count \> 3,000 per microliter or ANC \> 1500 per microliter
  * Serum calcium within normal limits.

Exclusion Criteria:

* A tumor that is too close to a major blood vessel (such as the carotid artery).
* A tumor invading the skull base.
* The tumor is not clearly shown on the CT image.
* The location and extension of the tumor precludes an effective I-PDT.
* Pregnant or has uncontrolled hyperglycemia.
* Has porphyria or other diseases exacerbated by light.
* With hypersensitivity to Temoporfin or to any of its excipients.
* Has known allergies/hypersensitivity to porphyrins.
* Has known sensitivity to the CT contrast agent. (Omnipaque)
* Has poor renal function as demonstrated by serum creatinine and EGFR \<40, which would preclude the using of the CT contrast agent.
* Patient with a planned surgical procedure within the next 30 days.
* Has a coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
* Patient with existing therapy with a photosensitizing agent (Temoporfin, protoporphyrin or derivatives of porphyrin).
* Has received prior photodynamic therapy to the proposed treatment site within the prior 3 months.
* Has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
* Has a childbearing potential and will not use adequate contraceptive protection.
* A female that is breastfeeding.
* Patient of childbearing potential who has a positive (+) urine pregnancy test.
* Received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
* Received radiotherapy to the head and neck region within the prior 3 months.
* Any disease, which is caused or exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid or xeroderma pigmentosum.
* Has been treated within the prior 30 days with a light-activated therapy or other medication that may render the subject photosensitive (e.g., psoralen ultraviolet A-range \[PUVA\], Accutane, 5-Fluorouracil, tetracycline's ).
* Not willing or able to complete the visit requirements of this protocol or adhere to the instructions regarding light exposure.
* Any other condition that the PI staff feels will be an endangerment to the subject.