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Immunotherapy + Chemotherapy for Uveal Melanoma
Study Summary
This trial is studying autologous CD8+ T cells, which are collected from patients' blood and treated to target melanoma cells, when given with other drugs to see how well they work in treating patients with metastatic uveal melanoma.
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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- I am fully active or can carry out light work.It has been over 4 weeks since my last cancer treatment or major surgery.Your hematocrit level is at least 24% or your hemoglobin level is at least 8 g/dL.I have another cancer type but it doesn't need treatment right now.You have tested positive for HIV, Hepatitis B, or Hepatitis C.You have received another type of immunotherapy treatment that the principal investigator believes would not be safe to combine with this study's treatment.Your white blood cell count is less than or equal to 2000 per microliter.Your platelet count is less than or equal to 50,000.I haven't taken high doses of steroids 3 days before and during T cell therapy.I haven't had vaccines for infectious diseases around the time I received ipilimumab.I am not on any cancer treatments not approved in this study.My cancer cells show specific immune system markers.I am using birth control to prevent pregnancy during the study.I am fully active or restricted in physically strenuous activity but can do light work.Side effects from my previous treatments are mild or back to normal, except for those that won’t improve.My side effects from previous treatments have mostly gone away or are permanent.Your platelet count is higher than 50,000.I have serious lung problems confirmed by my doctor.My cancer can be measured by touch or scan.I am not pregnant, nursing, and if of childbearing potential, I agree to use effective contraception.I do not have a history of inflammatory bowel disease or any autoimmune diseases.My liver enzymes are high due to liver metastasis.I have serious heart problems.Your hematocrit (Hct) level is 24% or lower, or your hemoglobin (Hb) level is 8 grams per deciliter or lower.I am a man willing to use birth control if my partner can become pregnant.I am willing and able to give my consent for treatment at least a week before T cell infusion.My melanoma was confirmed by a tissue examination at the time it spread or was diagnosed as high-risk.Your white blood cell count is too low.Your creatinine levels are three times higher than the normal range.Your bilirubin levels are three times higher than the normal range.My cancer has spread to my liver.
- Group 1: Treatment (cyclophosphamide, T-cells, aldesleukin, ipilimumab)
- 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
Are there still vacancies available in this experiment for participants?
"According to the information posted on clinicaltrials.gov, this investigation is actively hunting for qualified participants; it was initially published on September 8th 2017 and the listing most recently saw an update on October 6th 2022."
What risks do Autologous CD8+ SLC45A2-specific T Lymphocytes pose to users?
"Autologous CD8+ SLC45A2-specific T Lymphocytes has limited data in terms of efficacy and safety, thus our team at Power rates its risk as a 1."
What prior research has been completed regarding Autologous CD8+ SLC45A2-specific T Lymphocytes?
"Presently, 1148 clinical trials are underway studying Autologous CD8+ SLC45A2-specific T Lymphocytes; of which 193 are in the final stage. Most of these experiments take place within Philadelphia, Pennsylvania but there exist 48407 other sites conducting similar research."
What medical maladies can be managed through the application of Autologous CD8+ SLC45A2-specific T Lymphocytes?
"Autologous CD8+ SLC45A2-specific T Lymphocytes is a common cancer treatment for lung cancers and can also be beneficial in the management of acute myelocytic leukemia, multiple sclerosis, and unresectable melanoma."
How many participants are currently being recruited for this clinical research?
"Affirmative. Clinicaltrials.gov reports that this clinical trial was first uploaded on September 8th, 2017 and has been recently updated on October 6th, 2022. The study is seeking 30 individuals from one medical centre."
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