- - Patients with a histologically confirmed diagnosis of head and neck squamous cell
carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
- - Progressive squamous cell cancer of the head and neck or metastatic melanoma since
prior systemic treatment and who are:
Not candidates for known curative intent therapy.
2. Progressed following at least one prior systemic therapy.
3. Have advanced melanoma unresectable stage III or stage IV
4. Have advanced head and neck recurrent or metastatic disease
- - Have no more than 3 brain metastases.
Note: If lesions are symptomatic or ≥ 1 cm each,
these lesions must have been treated and stable for 3 months for the patient to be
- - Life expectancy of greater than 3 months.
- - ECOG Performance Status of 0 or 1.
- - Adequate organ and marrow function
- Seronegative for HIV antibody.
- - Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
- - More than four weeks has elapsed since the patient received any prior systemic therapy
at the time of enrollment.
- - Patient has stable or progressing disease after at least one prior treatment.
- - Six weeks or more have elapsed since the patient received any prior anti-CTLA4
- Currently using investigational agents.
- - Had prior cell transfer therapy which included a non-myeloablative or myeloablative
- - Patient is a female of child-bearing potential who is pregnant or breastfeeding
- Patient requires immune suppressive therapy including but not limited to greater than
physiologic steroid replacement.
- - Active systemic infections, coagulation disorders or other active major medical
illnesses of the cardiovascular, respiratory or immune system, as evidenced by a
positive stress thallium or comparable test, myocardial infarction, cardiac
arrhythmias, obstructive or restrictive pulmonary disease.
- - Patient has any form of primary immunodeficiency (such as Severe Combined
Immunodeficiency Disease and AIDS).
- - Patient has opportunistic infections.
- - Patient has a history of coronary revascularization or ischemic symptoms.
- - Patients with clinically significant atrial and/or ventricular arrhythmias including
but not limited to: atrial fibrillation, ventricular tachycardia, second or third
degree heart block.