Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zaawansowany nowotwór złośliwy z przerzutami (przewód pokarmowy, wątroba, układ moczowo-płciowy, pierś, jajniki/macica lub nowotwory neuroendokrynne) z co najmniej jednym guzem, który można bezpiecznie usunąć chirurgicznie
- •Potwierdzenie rozpoznania nowotworu złośliwego z przerzutami przez laboratorium patologiczne
- •BrakResponse na standardowe leczenie (zastosowane wcześniej: dla raka jelita grubego - oksaliplatyna lub irynotekan; dla raka wątroby - sorafenib; dla raka piersi/jajników - co najmniej dwa schematy chemioterapii)
- •Jeśli są przerzuty do mózgu: max 3 przerzuty, każdy poniżej 1 cm, bez objawów, albo wyleczone promieniowaniem lub operacją
- •Wiek od 18 do 72 lat
- •Dobry stan ogólny pacjenta (ECOG 0-1)
- •Gotowość stosowania antykoncepcji od włączenia do badania przez 12 miesięcy po leczeniu (kobiety) lub 4 miesiące (mężczyźni)
- •Dla kobiet: ujemny test ciążowy przed rozpoczęciem leczenia
✗ Disqualifies
- •Pozytywny test na HIV
- •Pozytywny test na antygen zapalenia wątroby typu B lub przeciwciała na zapalenie wątroby typu C (chyba że RNA HCV ujemne)
- •Liczba neutrofili poniżej 1000/mm³ (bez wsparcia lekami)
- •Liczba białych ciałek krwi poniżej 2500/mm³
- •Liczba płytek krwi poniżej 80 000/mm³
- •Hemoglobina poniżej 8,0 g/dL
- •Enzymy wątroby (ALT/AST) powyżej 5 razy normy
- •Kreatynina powyżej 1,5 razy normy
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 72 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
NCI/Surgery Branch Recruitment Center
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.