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 is this study for? Patients with non-small cell lung cancer
What treatments are being studied? Aldesleukin+Fludarabine+Cyclophosphamide+Young TIL
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 18-70 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. ...

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.)

• 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.

• All patients must have had at least one appropriate first line systemic therapy and progressed.

• Clinical performance status of ECOG 0 or 1.

• Age Greater than or equal to 18 years of age and less than or equal to 70 years of age.

• Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.

• Willing to sign a durable power of attorney

• Able to understand and sign the Informed Consent Document

• I. Hematology:

• Absolute neutrophil count greater than 1000/mm3 without support of filgrastim

• Normal WBC (> 2500/mm3).

• Hemoglobin greater than 8.0 g/dl. Subjects may be transfused to reach this cut-off.

• Platelet count greater than 80,000/mm3

• 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 RTPCR and be HCV RNA negative.

• k. Chemistry:

• Serum ALT/AST less than or equal to2.5 times the upper limit of normal.

• Serum creatinine less than or equal to 1.6 mg/dl.

• Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert s Syndrome, who must have a total bilirubin less than or equal to 3 mg/dl.

• l.Women of child-bearing potential must be willing to undergo a pregnancy testprior 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
Recruiting
Bethesda
Contact Information
Primary
NCI SB Immunotherapy Recruitment Center
irc@nih.gov
(866) 820-4505
Time Frame
Start Date: October 23, 2014
Estimated Completion Date: October 23, 2025
Participants
Target number of participants: 85
Treatments
Experimental: 1/High-Dose Aldesleukin
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine plus young TIL plus high-dose Aldesleukin
Experimental: 2/Low-Dose Aldesleukin
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine plus young TIL plus low-dose Aldesleukin
Authors
James C Yang
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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