A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck
- Patients must have documented histological or cytological evidence of tumor(s) of the
head and neck
- Patients must have one or more refractory and/or recurrent tumors of the head and
neck which have at least one dimension with longest diameter 15 mm using conventional
techniques or 10 mm with spiral CT scan.
- Target lesions should be accessible to examination (examination by fiber optic
nasopharyngoscopy or laryngoscopy is permitted) and to biopsy.
- Each index lesion should be large enough to provide at least 6 mg of tumor tissue by
biopsy (such as an 18 gauge Tru-Cut needle biopsy 1cm in length or similar technique)
for assessment by neutron activation analysis.
- Tumors must be measurable according to RECIST criteria
- Patients must be ≥ 18 years of age
- Patients must have ECOG Performance Score of 0, 1 or 2 (see Appendix 3)
- Patients or their legal representative must be able to read, understand and sign an
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL
- Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 2.0 mg/dL,
Alkaline phosphatase ≤ 2X the ULN for the reference lab, SGOT/SGPT ≤ 2X the ULN for
the reference lab
- Women of childbearing potential must agree to use an effective form of contraception
during the study and for 90 days following treatment (an effective form of
contraception is an oral contraceptive or a double barrier method). Women who are
NOT of childbearing potential are those who have undergone a bilateral oophorectomy
or who have undergone menopause, defined as an absence of a menstrual cycle for 12
- Negative pregnancy test for women of childbearing potential.
- Patients with known hypersensitivity to any of the components of the PEGylated
AuroShell suspension (polyethylene glycol, gold)
- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within a period of 5 half-lives of the investigational
therapy in question prior to the day of dosing with the PEGylated AuroShell particles
(investigational therapy is defined as treatment for which there is currently no
regulatory authority approved indication)
- Patients who are pregnant and/or lactating
- Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC
(101.3 ºF) within 3 days of the first scheduled day of dosing
- Patients who have undergone splenectomy
- Patient who has had a course of radiotherapy in the treatment area within the past 30
- Patient who has had a course of chemotherapy or other anti-neoplastic therapy in the
past 30 days.
- Patient who has had surgery within 2 cm of the treatment area within the past two
- Life expectancy of less than 3 months.
- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.