RECRUITING

T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

Conditions

Advanced Non-Small Cell Lung Cancer Squamous Cell Carcinoma Advanced NSCLC Adenosquamous Carcinoma Adenocarcinoma Metastatic Non-Small Cell Lung Cancer NSCLC Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with NSCLC who have a tumor that can be safely removed. Design: * Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed * Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. * Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} * Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.

Official Title

A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen

Quick Facts

Study Start:2014-10-23

Study Completion:2027-10-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02133196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 72 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.) 2. 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. 3. All patients must have had at least one appropriate first line systemic therapy and progressed. 4. Clinical performance status of ECOG 0 or 1. 5. Age \>= 18 years of age and \<= 72 years of age. 6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child. 7. Willing to sign a durable power of attorney 8. Able to understand and sign the Informed Consent Document * Absolute neutrophil count \> 1000/mm\^3 without support of filgrastim * Normal WBC (\>= 2500/mm\^3). * Hemoglobin \> 8.0 g/dl. Subjects may be transfused to reach this cut-off. * Platelet count \>= 80,000/mm\^3 * Seronegative for 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 may be less responsive to the experimental treatment and more susceptible to its toxicities.) * Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. * Serum ALT/AST \<= 2.5 times the upper limit of normal. * Serum creatinine \<= 1.6 mg/dl. * Total bilirubin \<= 2 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \<= 3 mg/dl.	1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant. 2. Ongoing need for pharmacological immunosuppression, including steroids 3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses 4. Major bronchial occlusion or bleeding not amenable to palliation. 5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency 6. 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.) 7. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \<= 45%. 9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \<= 50% 10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm: * Greater than 2 invasive thoracic procedures * Poor exercise tolerance * Greater than 66 years of age * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose. 11. Patients who are receiving any other investigational agents.

Inclusion Criteria

Exclusion Criteria

1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)
2. 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.
3. All patients must have had at least one appropriate first line systemic therapy and progressed.
4. Clinical performance status of ECOG 0 or 1.
5. Age \>= 18 years of age and \<= 72 years of age.
6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.
7. Willing to sign a durable power of attorney
8. Able to understand and sign the Informed Consent Document
* Absolute neutrophil count \> 1000/mm\^3 without support of filgrastim
* Normal WBC (\>= 2500/mm\^3).
* Hemoglobin \> 8.0 g/dl. Subjects may be transfused to reach this cut-off.
* Platelet count \>= 80,000/mm\^3
* Seronegative for 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 may be less responsive to the experimental treatment and more susceptible to its toxicities.)
* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
* Serum ALT/AST \<= 2.5 times the upper limit of normal.
* Serum creatinine \<= 1.6 mg/dl.
* Total bilirubin \<= 2 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \<= 3 mg/dl.

1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.
2. Ongoing need for pharmacological immunosuppression, including steroids
3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses
4. Major bronchial occlusion or bleeding not amenable to palliation.
5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
6. 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.)
7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \<= 45%.
9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \<= 50%
10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:
* Greater than 2 invasive thoracic procedures
* Poor exercise tolerance
* Greater than 66 years of age
* Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.
11. Patients who are receiving any other investigational agents.

Contacts and Locations

Study Contact

NCI SB Immunotherapy Recruitment Center

CONTACT

(866) 820-4505

irc@nih.gov

Principal Investigator

James C Yang, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

James C Yang, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-10-23

Study Completion Date2027-10-23

Study Record Updates

Study Start Date2014-10-23

Study Completion Date2027-10-23

Terms related to this study

Keywords Provided by Researchers

Metastatic
Non-Small Cell Lung Cancer
NSCLC
Lung Cancer

Additional Relevant MeSH Terms

Advanced Non-Small Cell Lung Cancer
Squamous Cell Carcinoma
Advanced NSCLC
Adenosquamous Carcinoma
Adenocarcinoma