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Adoptive Cell Therapy for Sarcoma
Study Summary
This trial will test a new cancer treatment involving injecting immune cells into tumors. The goal is to see if it is safe and if the immune cells can survive in the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My kidney, liver, and blood tests are within normal ranges.I am not on long-term steroids for immune suppression.I've completed a specific chemotherapy aimed at boosting my immune system.I meet all the requirements for the study at the time of my tumor removal and TIL expansion.I have good energy levels, at least half of my usual.My disease may be stable or worsening after treatment not in the trial, before TIL transfer.I do not have any active infections, bleeding disorders, or major illnesses affecting my heart, lungs, or immune system.I have a high-grade, metastatic soft tissue sarcoma.My previously harvested immune cells are stored and meet the trial's standards.My condition worsened after treatment for my spreading cancer.I understand the study and can give my consent.I still have visible cancer after surgery aimed at growing immune cells.I do not have HIV, hepatitis B, HTLV I/II, or untreated syphilis. If I have hepatitis C, it is undetectable.My heart's pumping ability is good, as shown by a recent test.My lung function tests are recent and show FEV1 or FVC greater than 65% of what's expected.My recent heart test shows no new issues, or if there are, a stress test cleared me.I have tested positive for EBV antibodies.I do not have cancer that has spread to my brain.I do not take immunosuppressive drugs for an autoimmune disease.
- Group 1: Infusion of Tumor-infiltrating lymphocyte
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do I fulfill the conditions to partake in this clinical experiment?
"This clinical trial is open to 10 people aged 18-39 with sarcoma who meet the following criteria: Eastern Cooperative Oncology Group (ECOG) 0 to 1; ECOG performance status of 0 to 1 inferred if patient's energy level is ≥ 50% of baseline; negative pregnancy test for women of childbearing potential at screening; willingness and availability to comply with all study procedures, as well as having progressed on one standard prior care treatment regimen."
What is the maximum capacity for this research project?
"Unfortunately, this medical trial has closed its recruitment period; it was initially noticed on September 27th 2019 and went through a final editing process on November 10th 2022. However, there are currently 443 clinical trials for sarcoma patients and 901 TIL studies that can accept participants."
Has there been any precedent for the application of TIL in research studies?
"At the present time, there are 901 research studies that are utilizing TIL as part of their protocol. Out of these trials, 161 have entered Phase 3 testing. Of these 161 trails, most are located in Philadelphia but they span 28476 sites across the globe."
What medical purpose is tumor infiltrating lymphocytes usually used for?
"TIL is often used to mitigate multiple sclerosis, but it also has applications for acute leukemia, myelocytic lymphoma, retinoblastoma, and histiocytosis."
What risks do individuals face when undergoing TIL treatment?
"TIL's safety is presumed to be high, as it has only been in the first phase of clinical trials. Thus, our analysis assigns a score of 1 for this drug’s safety profile."
Are there still vacancies for participants in this investigation?
"Unfortunately, this particular study has ceased recruitment of patients. It was originally made available on September 27th 2019 and the last changes were recorded November 10th 2022. However, there are currently 443 clinical trials actively seeking sarcoma patient participants as well as 901 recruiting for TIL therapy."
Does this investigation include individuals aged 40 or older?
"The requirements for this clinical trial necessitate that participants must be between 18-39 years old. By contrast, there are 468 trials available to those below the age of consent and 1041 studies appropriate for individuals older than 65."
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