Status:
COMPLETED
T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Vaginal Cancer
Cervical Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing...
Detailed Description
BACKGROUND: * Metastatic or refractory/recurrent human papillomavirus (HPV)-16+ cancers (cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers) are incurable and poorly palliated by stan...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Measurable metastatic or refractory/recurrent human papilloma virus (HPV-16+) cancer (determined by in situ hybridization (ISH) or a polymerase chain reaction (PCR)-based test).
- Patients must be human leukocyte antigens (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.
- Greater than or equal to 18 years of age and less than or equal to 70 years of age.
- 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 because of the potentially dangerous effects of the treatment on the fetus.
- Serology:
- Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)
- 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 transcription polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.
- Hematology:
- Absolute neutrophil count greater than 1000/mm\^3 without the support of filgrastim.
- White blood cell (WBC) greater than or equal to 3000/mm\^3
- Platelet count greater than or equal 100,000/mm\^3
- Hemoglobin greater than 8.0 g/dL
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 2.5 times the upper limit of normal
- Serum creatinine less than or equal to 1.6 mg/dL
- Total bilirubin less than or equal to to 1.5 mg/dL, except in patients with Gilberts 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.
- EXCLUSION CRITERIA:
- Women of childbearing potential who are pregnant or breastfeeding. There are potentially dangerous side effects of the treatment on the fetus or infant.
- 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 (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- Concurrent systemic steroid therapy.
- History of severe immediate hypersensitivity reaction to cyclophosphamide or 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
- a. clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or
- b. age greater than or equal 60 years old
Exclusion
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02280811
Start Date
October 14 2014
End Date
June 28 2016
Last Update
September 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892