Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 4:40 AM
Study NCT ID:
NCT04044950
Status:
WITHDRAWN
Last Update Posted:
2020-09-22
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Researchers have found a new way to treat cancer. The therapy used in this study is called E7 TCR T cell therapy. This therapy is a type of treatment in which a participant s T cells (a type of immune system white blood cell) are changed in the laboratory to attack cancer cells. This treatment might help people with human papilloma virus (HPV)-associated oropharyngeal cancer. Oropharyngeal cancer is a type of head and neck cancer that happens in the oropharynx (the part of the throat at the back of the mouth, including the soft palate, the base of the tongue and the tonsils). Certain types of the HPV virus can cause this kind of cancer and this study is looking at those cause by HPV-16.
Objective: The purpose of this study is to find out if injecting E7 TCR T cells directly into cancer tumor(s) can be done without delaying standard treatment for stage I oropharyngeal cancer, which may include surgery or radiation therapy with chemotherapy.
Eligibility: People aged 18 and older with borderline resectable or unresectable Stage I, HPV-16 associated oropharyngeal cancer.
Design: Participants will be screened with HLA typing (a blood test needed for eligibility) and HPV testing of the cancer tumor (to determine if the cancer is HPV-16 positive). A new biopsy may be needed if tumor from an outside location is not available for HPV testing. Eligible participants will come to the NIH campus to have a screening evaluation which will include physical exam, review of medical history and current medications, blood and heart tests, imaging (X-ray, CT scan, MRI or PET scan), and evaluation of participant s veins that are used for drawing blood.
If the participant is eligible for the study based on the screening evaluation, they will have a baseline evaluation prior to receiving the experimental treatment which may include additional laboratory or imaging tests. A biopsy of the primary tumor may be performed before getting the cell injection and approximately 4 weeks after the cell injection.
Participants will have a large IV catheter inserted into a vein to undergo a procedure called leukapheresis. Leukapheresis is the removal of the blood by a machine to collect specific white blood cells. The remaining blood is returned to the body. This procedure is needed to collect the cells that will be modified to target the cancer. The cells are grown in the lab and given back to the participant through an injection into the participant's tumor. It takes 11-15 days to grow the cells.
Once the cells are ready, participants will receive an injection of E7 TCR T cells directly into the primary tumor and any lymph nodes that can be seen or felt on physical exam. The injection will be done in the clinic or the operating room and may require general anesthesia. Participants will recover in the hospital until they are well enough to go home, which will be about 1-2 days after the cell injection.
Participants will have follow-up visits starting 2 weeks after cell injection. These will be visits to monitor the safety of the treatment and to evaluate the response of the cancer to the treatment. If the cancer appears to be growing at the 2-week visit, participants will go back to their local doctor for further care. If the cancer is not growing, participants will return for another follow-up visit 4 weeks after cell injection to see how the cancer is responding. Regardless of whether the cancer is shrinking or not, all participants will be referred to their home physician for further care after the 4-week visit.
After receiving cell therapy, participants will be followed on a long-term gene therapy protocol. Participants will have blood drawn periodically to test if the cells have grown or changed. These blood tests will take place immediately before the cells, and then at 3, 6, 12 months for the first year and then annually. These tests can be drawn locally and sent to the NIH. Participants will be asked to return to the NIH annually for a physical examination for 5 years after they receive the cell injection. If participants are not able, to return to the NIH annually, they may be contacted at home and asked to have records sent from their local doctor. After that time, participants will be asked to fill -out a questionnaire for the next ten years, for a total follow-up period of 15 years.
Objective: The purpose of this study is to find out if injecting E7 TCR T cells directly into cancer tumor(s) can be done without delaying standard treatment for stage I oropharyngeal cancer, which may include surgery or radiation therapy with chemotherapy.
Eligibility: People aged 18 and older with borderline resectable or unresectable Stage I, HPV-16 associated oropharyngeal cancer.
Design: Participants will be screened with HLA typing (a blood test needed for eligibility) and HPV testing of the cancer tumor (to determine if the cancer is HPV-16 positive). A new biopsy may be needed if tumor from an outside location is not available for HPV testing. Eligible participants will come to the NIH campus to have a screening evaluation which will include physical exam, review of medical history and current medications, blood and heart tests, imaging (X-ray, CT scan, MRI or PET scan), and evaluation of participant s veins that are used for drawing blood.
If the participant is eligible for the study based on the screening evaluation, they will have a baseline evaluation prior to receiving the experimental treatment which may include additional laboratory or imaging tests. A biopsy of the primary tumor may be performed before getting the cell injection and approximately 4 weeks after the cell injection.
Participants will have a large IV catheter inserted into a vein to undergo a procedure called leukapheresis. Leukapheresis is the removal of the blood by a machine to collect specific white blood cells. The remaining blood is returned to the body. This procedure is needed to collect the cells that will be modified to target the cancer. The cells are grown in the lab and given back to the participant through an injection into the participant's tumor. It takes 11-15 days to grow the cells.
Once the cells are ready, participants will receive an injection of E7 TCR T cells directly into the primary tumor and any lymph nodes that can be seen or felt on physical exam. The injection will be done in the clinic or the operating room and may require general anesthesia. Participants will recover in the hospital until they are well enough to go home, which will be about 1-2 days after the cell injection.
Participants will have follow-up visits starting 2 weeks after cell injection. These will be visits to monitor the safety of the treatment and to evaluate the response of the cancer to the treatment. If the cancer appears to be growing at the 2-week visit, participants will go back to their local doctor for further care. If the cancer is not growing, participants will return for another follow-up visit 4 weeks after cell injection to see how the cancer is responding. Regardless of whether the cancer is shrinking or not, all participants will be referred to their home physician for further care after the 4-week visit.
After receiving cell therapy, participants will be followed on a long-term gene therapy protocol. Participants will have blood drawn periodically to test if the cells have grown or changed. These blood tests will take place immediately before the cells, and then at 3, 6, 12 months for the first year and then annually. These tests can be drawn locally and sent to the NIH. Participants will be asked to return to the NIH annually for a physical examination for 5 years after they receive the cell injection. If participants are not able, to return to the NIH annually, they may be contacted at home and asked to have records sent from their local doctor. After that time, participants will be asked to fill -out a questionnaire for the next ten years, for a total follow-up period of 15 years.
Detailed Description:
Background:
* Human papillomavirus (HPV)+ oropharyngeal cancer is an increasingly common type of cancer that frequently affects young patients.
* Although the prognosis of early-stage cancer is favorable, the treatments can result in significant life-long morbidity.
* Neoadjuvant therapy is an active area of investigation. The goal of neoadjuvant therapy in this setting is to reduce the risk of disease recurrence and permit the study of de- intensified definitive treatment of early-stage disease.
* E7 TCR T cells have demonstrated safety and clinical activity in treatment-refractory metastatic HPV+ cancers.
Objectives:
\- To determine the feasibility of intratumoral injection of E7 TCR T cells as neoadjuvant therapy for borderline resectable and unresectable stage I HPV+ oropharyngeal cancer.
Eligibility:
\- Patients greater than or equal to 18 years of age with borderline resectable or unresectable stage I HPV+ oropharyngeal cancer.
Design:
* This is a phase II, single arm, feasibility study of neoadjuvant E7 TCR T cell therapy for borderline resectable and unresectable stage I HPV+ oropharyngeal cancer.
* Patients will receive intratumoral injection of E7 TCR T cells into the primary tumor and involved regional lymph nodes
* Patients will not receive a conditioning chemotherapy regimen or systemic aldesleukin
* Patients will be referred for definitive standard of care therapy following completion of protocol therapy
* Human papillomavirus (HPV)+ oropharyngeal cancer is an increasingly common type of cancer that frequently affects young patients.
* Although the prognosis of early-stage cancer is favorable, the treatments can result in significant life-long morbidity.
* Neoadjuvant therapy is an active area of investigation. The goal of neoadjuvant therapy in this setting is to reduce the risk of disease recurrence and permit the study of de- intensified definitive treatment of early-stage disease.
* E7 TCR T cells have demonstrated safety and clinical activity in treatment-refractory metastatic HPV+ cancers.
Objectives:
\- To determine the feasibility of intratumoral injection of E7 TCR T cells as neoadjuvant therapy for borderline resectable and unresectable stage I HPV+ oropharyngeal cancer.
Eligibility:
\- Patients greater than or equal to 18 years of age with borderline resectable or unresectable stage I HPV+ oropharyngeal cancer.
Design:
* This is a phase II, single arm, feasibility study of neoadjuvant E7 TCR T cell therapy for borderline resectable and unresectable stage I HPV+ oropharyngeal cancer.
* Patients will receive intratumoral injection of E7 TCR T cells into the primary tumor and involved regional lymph nodes
* Patients will not receive a conditioning chemotherapy regimen or systemic aldesleukin
* Patients will be referred for definitive standard of care therapy following completion of protocol therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 19-C-0130 | None | None | View |