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