T-cell Receptor Gene Therapy Targeting HPV-16 E6 in Treating Patients with Metastatic, Recurrent, or Refractory HPV-Related Cancer

Inclusion Criteria

• Measurable metastatic or refractory/recurrent HPV-16+ cancer (determined by in situ hybridization [ISH] or a polymerase chain reaction [PCR]-based test)
• Patients must be human leukocyte antigen (HLA)-A*02:01-positive
• All patients must have received prior first line standard therapy or declined standard therapy, and have been either non-responders (progressive disease) or have recurred
• Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible; lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible; patients with surgically resected brain metastases are eligible
• Able to understand and sign the informed consent document
• Willing to sign durable power of attorney
• Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Life expectancy of greater than 3 months
• Patients of both genders must be willing to practice birth control from the time of enrollment on this study up to 4 months after treatment; patients must be willing to undergo testing for HPV-16 prior to becoming pregnant
• Women of child bearing potential must have a negative pregnancy test
• Seronegative for human immunodeficiency virus (HIV) antibody
• Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase (RT)-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
• Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
• White blood cell (WBC) >= 3000/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin > 8.0 g/dL
• Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< to 2.5 times the upper limit of normal
• Serum creatinine =< to 1.6 mg/dL
• Total bilirubin =< to 1.5 mg/dL, except in patients with Gilbert’s syndrome who must have a total bilirubin less than 3.0 mg/dL
• More than 4 weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen; note: patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria

Exclusion Criteria

• Women of childbearing potential who are pregnant or breastfeeding
• Active systemic infections (for e.g.: requiring anti-infective treatment), 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
• Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
• Concurrent opportunistic infections
• Concurrent systemic steroid therapy
• History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine phosphate (fludarabine)
• History of coronary revascularization or ischemic symptoms
• Documented left ventricular ejection fraction (LVEF) of less than or equal to 45% tested; the following patients will undergo cardiac evaluations * Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or * Age >= 60 years old