Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers - PHASE II PILOT STUDY

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.