Actively Recruiting
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-08
332
Participants Needed
1
Research Sites
1009 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. 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 digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy. 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 will take up to 2 days. ...
CONDITIONS
Official Title
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable metastatic cancer of the digestive tract, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors
- At least one tumor lesion that can be surgically removed with minimal risk
- Diagnosis confirmed by NCI Laboratory of Pathology
- Cancer refractory to approved standard systemic therapy (specific prior treatments required depending on cancer type)
- Up to 3 brain metastases smaller than 1 cm and asymptomatic, or surgically resected brain metastases
- Age between 18 and 72 years
- ECOG performance status of 0 or 1
- Willingness to practice birth control during and after treatment if of child-bearing potential
- Negative pregnancy test for individuals who can become pregnant
- Seronegative for HIV, hepatitis B antigen, and hepatitis C antibody (with further testing if needed)
- Adequate blood counts (ANC > 1000/mm³, WBC ≥ 2500/mm³, platelets ≥ 80,000/mm³, hemoglobin > 8.0 g/dL)
- Liver and kidney function within specified limits (ALT/AST ≤ 5x ULN, creatinine ≤ 1.5x ULN, bilirubin ≤ 2.0 mg/dL or ≤ 3.0 mg/dL with Gilbert's Syndrome)
- Completed any prior systemic therapy before enrollment
- Able to understand and sign informed consent
- Willing to sign a durable power of attorney
- Must be co-enrolled on protocol 03-C-0277
You will not qualify if you...
- Pregnant or nursing individuals
- Current systemic steroid therapy
- Active infections requiring treatment, coagulation disorders, or other major uncompensated medical illnesses
- Advanced primary tumors causing obstruction, perforation, bleeding, or requiring transfusion
- Primary immunodeficiency diseases
- History of major organ autoimmune disease
- Severe immune-related adverse events from prior anti-PD-1/PD-L1 therapy
- Opportunistic infections
- Severe allergic reactions to cyclophosphamide, fludarabine, or aldesleukin
- History of coronary revascularization or ischemic symptoms
- Left ventricular ejection fraction ≤ 45% if cardiac evaluation indicated
- Child-Pugh score B or C in hepatocellular carcinoma with liver dysfunction
- Forced expiratory volume in 1 second (FEV1) ≤ 50% if pulmonary evaluation indicated
- Receiving other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI/Surgery Branch Recruitment Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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