RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 72 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 2 days, 5 years
  • Procedures mentioned: Physical exams, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Assignment to this cohort will be made if there are concomitant medical conditions that would preclude the use of high-dose aldesleukin * Clinical and immunologic response will be evaluated about 4-6 weeks after TIL infusion. * For both cohorts 1 and 2, using a Phase II design, 21 patients will be initially enrolled in each group to assess toxicity and tumor responses."
  • "In order to allow for a small number of non evaluable patients, a total of 85 patients may be enrolled over 5 years."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether selected white blood cells taken from a person's tumor can shrink non-small cell lung cancer and be safe. It is for adults ages 18–72 whose cancer has spread or cannot be fully removed by surgery. Treatment includes growing these cells in a lab, giving them back with chemotherapy and a drug called aldesleukin, and about 4 weeks in the hospital.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 18–72, with cancer that can be measured and at least one tumor that can be safely removed to grow the study cells.
  • Have cancer that got worse after at least one standard first treatment for the whole body. Prior whole-body treatment must be finished before joining.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Brain tumors may be allowed: up to 3 small tumors under 1 cm with no symptoms. Tumors treated with focused radiation must be stable for 1 month; surgically removed brain tumors are also allowed.
  • Meet blood count, liver, and kidney test limits. Have no HIV or active hepatitis B; a positive hepatitis C antibody test requires a negative test for the virus.
  • If able to become pregnant, show you are not pregnant and use birth control from enrollment through 12 months after the last chemotherapy dose. If able to father a child, use birth control through 4 months after treatment.
  • Understand and sign the consent form, agree to name someone to make decisions for you if needed, and also join study 03-C-0277.
  • Recover enough from recent treatments. Wait more than 2 weeks after treatment to ease a major airway blockage or bleeding before starting study preparation.

Who can't join

  • Have a neuroendocrine tumor, a type of tumor not included in this study, or be breastfeeding.
  • Need ongoing medicines that weaken the immune system, including steroids, or have a serious immune system disorder.
  • Have an active infection, a blood-clotting disorder, or another serious illness that is active or not controlled.
  • Have a major airway blockage or bleeding that cannot be eased with treatment.
  • Have had a severe, immediate allergic reaction to any study drug.
  • If heart or lung testing is needed, have heart pumping strength of 45% or less, or a breathing test result called FEV1 of 50% or less.
  • For high-dose aldesleukin only: be older than 66, have had more than 2 invasive chest procedures, have trouble with exercise, or have a health history that makes the dose unsafe. Low-dose treatment may still be possible.
  • Be receiving another experimental drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION 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 I. Hematology: * 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 j. Serology: * 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. k. Chemistry: * 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. l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus. m. Patients must have completed any prior systemic therapy at the time of enrollment. Note: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less. n. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less. o. Subjects must be co-enrolled in protocol 03-C-0277. EXCLUSION CRITERIA: 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 Disease and AIDS). 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.

Study sites (1)

MD

  • National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center · Study contact · 866-820-4505 · irc@nih.govMore trials in Bethesda