Status:
TERMINATED
E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Papillomavirus Infections
Oropharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: The therapy used in this study is called E7 T-cell receptor (TCR) T cell therapy. This therapy is a type of treatment in which a participant's T cells (a type of immune system cell) are c...
Detailed Description
Background: * Human papillomavirus (HPV)+ oropharyngeal cancer is an increasingly common type of cancer that frequently affects young patients. * The treatment for locoregionally advanced cancer carr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically or cytologically confirmed stage II or stage III (American Joint Committee on Cancer (AJCC) 8th edition) oropharyngeal squamous cell carcinoma that has not been treated.
- Human papillomavirus 16 (HPV16)+ tumor and human leukocyte antigen A (HLA-A) 02:01+ HLA type (HLA-A 02 is also acceptable for determination of eligibility).
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Patient age 18 and older. Because no dosing or adverse event data are currently available on the use of E7 T-cell receptor (TCR) T Cells in patients \<18 years of age, children are excluded from this study. This reflects the age range of patients with the disease being studied.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Women of child-bearing potential must have a negative pregnancy test because E7 TCR T Cells have unknown potential for teratogenic or abortifacient effects. Women of child-bearing potential are defined as all women who are not post-menopausal or who have not had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year.
- The effects of E7 TCR T Cells on the developing human fetus are unknown. For this reason and because the chemotherapy agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (intrauterine device, hormonal or barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- 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 be less responsive to the experimental treatment.
- Seronegative for hepatitis B antigen and 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.
- Must be willing to participate in Gene Therapy Long Term Followup Protocol, which will follow patients for up to 15 years per Food and Drug Administration (FDA) requirements.
- Patients must have organ and marrow function as defined below:
- leukocytes- greater than or equal to 3,000/mcL
- absolute neutrophil count- greater than or equal to 1,500/mcL
- platelets- greater than or equal to 100,000/mcL
- hemoglobin- greater than or equal to 9.0 g/dL
- total bilirubin- within normal institutional limits except in patients with Gilbert's Syndrome who must have a total bilirubin \< 3.0 mg/dL
- Aspartate aminotransferase (AST) Serum glutamic oxaloacetic transaminase(SGOT)/Alanine transaminase (ALT) Serum glutamic pyruvic transaminase(SGPT)-Serum ALT/AST \< 2.5 times upper limit of normal (ULN)
- creatinine clearance- Calculated creatinine clearance (CrCl) \>50mL/min/1.73m(2) for patients with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- EXCLUSION CRITERIA:
- Patients who are receiving any other investigational agents.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
- There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T Cells. For this reason, women may not breastfeed while receiving study treatment and for one year after the study treatment ends. These potential risks may also apply to other agents used in this study.
- Patients with any form of systemic immunodeficiency, including acquired deficiency such as human immunodeficiency virus (HIV) or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. 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 treatment.
- Current use of immunosuppressive medication, EXCEPT for the following:
- Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
- Systemic corticosteroids at physiologic doses less than equal to 10 mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions (e.g., computed tomography (CT) scan premedication)
- Patients with autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus. Hypothyroidism, vitiligo and other minor autoimmune disorders are not exclusionary.
- Patients with a second active invasive cancer are not eligible if it may confound assessment of response to the current therapy.
- Patients who do not have a local physician to provide standard therapy post treatment.
Exclusion
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04015336
Start Date
July 6 2020
End Date
July 15 2020
Last Update
February 24 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892