Immunotherapy for Metastatic Cancer Using Tumor Infiltrating Lymphocytes
This study is testing an experimental treatment for metastatic cancers, including colorectal, pancreatic, ovarian, breast, and neuroendocrine tumors. Researchers are investigating if a treatment called Tumor Infiltrating Lymphocytes (TIL) can shrink tumors. TIL are white blood cells taken from your own tumor, grown in the lab, and then given back to you. You would also receive chemotherapy drugs (Fludarabine and Cyclophosphamide), Aldesleukin (a medication to boost your immune system), and Pembrolizumab (Keytruda), an immunotherapy drug. The study aims to see how many patients respond to this treatment. You may be eligible if you are between 18 and 72 years old and have one of the specified metastatic cancers with a tumor that can be removed for TIL generation. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 332 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured at 6 and 12 weeks after cell infusion, then every 3 months for 9 months, then every 6 months for 2 years, and then as decided by the doctor.
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NCT01174121
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Recruiting
PHASE2Ages 18–72InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~332 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Pembrolizumab (Keytruda)FludarabineCyclophosphamideAldesleukinYoung TIL
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Steven A Rosenberg, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.
Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.
Refractory to approved standard systemic therapy. Specifically:
Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.
Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.
Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.
Patients with 3 or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Age greater than or equal to 18 years and less than or equal to 72 years.
Clinical performance status of ECOG 0 or 1.
Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.
IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.
Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
ANC \> 1000/mm\^3 without the support of filgrastim
WBC greater than or equal to 2500/mm\^3
Platelet count greater than or equal to 80,000/mm\^3
Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off.
Serum ALT/AST less than or equal to 5.0 x ULN
Serum creatinine less than or equal to 1.5 x ULN
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \< 3.0 mg/dL.
Patients must have completed any prior systemic therapy at the time of enrollment.
Ability of subject to understand and the willingness to sign a written informed consent document.
Willing to sign a durable power of attorney.
Subjects must be co-enrolled on protocol 03-C-0277.
Exclusion
Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
Concurrent systemic steroid therapy.
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
History of major organ autoimmune disease.
Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy.
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
History of coronary revascularization or ischemic symptoms.
For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.
For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.
Patients who are receiving any other investigational agents.
What this trial measures
- Response rate6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion
Percentage of patients who have a clinical response to treatment (objective tumor regression)