Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

Open to people ages 18 years and up

• 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.
• Progressed following at least one prior systemic therapy.
• Have advanced melanoma unresectable stage III or stage IV
• 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 eligible.
• 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 antibody therapy

• Currently using investigational agents.
• Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
• 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.