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E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer

2019-07-16 10:38:51 | BioPortfolio

Summary

Background:

The therapy called E7 TCR gives white blood cells new genes to attack cancer. This treatment might help people with human papilloma virus (HPV)-associated oropharyngeal cancer.

Objective:

To see if people with oropharyngeal cancer can be treated with E7 T cells before getting standard treatment.

Eligibility:

People ages 18-65 with Stage II or III HPV-16 associated oropharyngeal cancer

Design:

Participants will be screened with:

Physical exams

Medication history

Blood and heart tests

X-rays

Tumor tissue: If this is not available, they will have a biopsy.

Vein exam

Participants will have a catheter inserted into a vein in the chest.

Participants will have leukapheresis. Blood will be removed through a needle in one arm, move through a machine that takes out the white blood cells, then returned through a needle in the other arm. The white blood cells will be modified in the lab.

Participants will be admitted to the hospital a week before treatment. They will get chemotherapy and then the E7 TCR cells through the catheter. They will recover in the hospital for 7-12 days. They will get a drug through the catheter for 5 days. They may get an injection every day.

Participants will have visits every 2 weeks. This will continue until their disease goes away or the treatment stops working. Then they will have blood tests at months 3, 6, and 12 in the first year. Then they will have annual physical exams for 5 years. Then they will complete annual questionnaires for 10 years.

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 carries substantial life-long morbidity.

- Although the overall prognosis for HPV+ oropharyngeal cancer is favorable, about 20 percent of patients with stage II disease and 35 percent of patients with stage III disease will die within five years.

- Induction therapy is an area of active study in this type of cancer. The aims of induction therapy are to reduce the risk of disease recurrence and potentially to permit the study of de-intensified definitive treatment of locoregional disease.

- E7 TCR T cells, administered as a single infusion, have demonstrated safety and clinical activity in treatment-refractory metastatic HPV+ cancers.

Objectives:

-To determine the feasibility of systemic treatment with E7 TCR T cells for stage II or stage III HPV+ oropharyngeal cancer.

Eligibility:

- Patients greater than or equal to 18 years old and less than or equal to 66 years old with stage II or stage III HPV+ oropharyngeal cancer.

- The cancer must be HPV16+ and patient must be HLA-A 02:01+ HLA type.

- Patients must be treatment-naive.

Design:

- This is a phase II, single arm, feasibility study of induction E7 TCR T cell therapy.

- Patients will receive a conditioning regimen of cyclophosphamide and fludarabine, a single infusion of E7 TCR T cells, and systemic aldesleukin.

- Patients will be referred for standard of care definitive therapy (chemoradiation or surgery) at the time of maximum tumor response

Study Design

Conditions

Papillomavirus Infections

Intervention

E7 TCR

Location

National Institutes of Health Clinical Center
Bethesda
Maryland
United States
20892

Status

Not yet recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-16T10:38:51-0400

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