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Tumor Infiltrating Lymphocytes for Ovarian Cancer
Study Summary
This trial is testing how well autologous tumor-infiltrating lymphocytes work in treating patients with ovarian, colorectal, or pancreatic cancer that has come back or does not respond to treatment.
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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- I do not have any active infections needing IV antibiotics or major illnesses affecting my heart, lungs, or immune system.I have active viral hepatitis.Your heart's pumping function is lower than 45%.Your heart test (EKG) shows no current heart problems and your QT interval is less than 480 milliseconds.Before starting treatment, your blood tests need to show: enough white blood cells, a certain level of hemoglobin, a minimum number of platelets, normal liver function, and good kidney function.I have ovarian cancer and previous treatments with at least two types of chemotherapy did not work.My pancreatic cancer has not improved with initial treatment.I don't have severe side effects from previous treatments, except for nerve issues, hair loss, or skin color loss.You have a weakened immune system from birth.I have a history of significant autoimmune disease.If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before joining the study.You have good lung function as shown in breathing tests.I am on a low dose of steroids, less than 10 mg/day.I am not allergic to any components of the TIL therapy or study drugs.I have complications from a previous surgery that could make my upcoming treatment riskier.My colorectal cancer is at a stage where I can wait 7-8 weeks for treatment.I have pancreatic cancer but do not have ascites or carcinomatosis.My albumin level is at least 3.0 mg/dL.I stopped all cancer treatments 28 days before my tumor removal surgery.I have had cell therapy treatment before.I have a long-term lung condition like COPD or asthma.I have not received a live vaccine in the last 30 days.My heart test before starting treatment was normal.My ovarian cancer is high grade and not mucinous.My colorectal cancer has spread and cannot be cured with current treatments.I do not have HIV.I was diagnosed with another cancer type within the last 5 years.I am fully active or restricted in physically strenuous activity but can do light work.I have had an organ or bone marrow transplant.I have a tumor that can be partially removed for testing, separate from the main tumor being monitored.I have active brain metastases or cancer in the lining of my brain.My physical abilities have recently declined.I have pancreatic cancer and have had multiple treatments.I have a confirmed diagnosis of pancreatic cancer with limited spread.
- Group 1: Treatment (autologous tumor infiltrating lymphocytes MDA-TIL)
- 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
Is the age criterion for this clinical trial inclusive of geriatric individuals?
"This investigation is only open to individuals aged 18-70. For those outside this age bracket, there are a total of 6152 trials that cater to their demographic; 589 for minors and 5563 for seniors."
What evidence is there of prior research utilizing Autologous Tumor Infiltrating Lymphocytes MDA-TIL?
"At present, there are 901 active clinical trials investigating Autologous Tumor Infiltrating Lymphocytes MDA-TIL with 161 of them in their third phase. While Philadelphia, Pennsylvania is a major hub for these studies, 28476 other sites worldwide are working on the same research."
Has the FDA authorized Autologous Tumor Infiltrating Lymphocytes MDA-TIL for medical use?
"Autologous Tumor Infiltrating Lymphocytes MDA-TIL has been granted a score of 2 on the safety scale due to prior clinical data confirming its security, but no evidence suggesting it is efficacious."
Who meets the qualifications to participate in this trial?
"This clinical endeavour is admitting 27 individuals, aged between 18 and 70 years old, who have metastasized colorectal adenocarcinoma. Additionally, patients must satisfy the following standards: Accessibility of tumor for excisional biopsy (core biopsies may also be allowed) to generate TILs other than target lesions used for response assessment; termination of any prior therapies geared towards malignant tumour such as radiation therapy, chemotherapy or biological/targeted agents at least 28 days before resectioning the neoplasm to prepare TIL treatments; attaining an ECOG performance status either 0 or 1 within"
How has Autologous Tumor Infiltrating Lymphocytes MDA-TIL been used in therapeutic settings?
"Autologous Tumor Infiltrating Lymphocytes MDA-TIL is a potential treatment option for retinoblastoma, acute and myelocytic leukemia, and multiple sclerosis."
How many patients is the trial recruiting?
"At this time, no further participants are being accepted for the trial first posted on August 17th 2018. Alternatively, there are 5055 clinical trials actively looking to enrol patients with metastatic colorectal adenocarcinoma and another 901 studies seeking volunteers for Autologous Tumor Infiltrating Lymphocytes MDA-TIL."
Is there an ongoing recruitment of participants for this clinical trial?
"At this moment in time, no additional participants are being recruited for the trial which initially opened on August 17th 2018. For individuals looking for other studies, there is presently 5055 medical trials admitting patients with metastatic colorectal adenocarcinoma and 901 investigations taking partakers suffering from Autologous Tumor Infiltrating Lymphocytes MDA-TIL."
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What portion of applicants met pre-screening criteria?
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