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Genetically Modified T-Cells + Aldesleukin for Melanoma
Study Summary
This trial is testing genetically modified T-cells followed by aldesleukin to treat melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory. Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells.
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 have been active and mostly self-sufficient in the last month.I had a brain scan within the last 30 days.My melanoma has spread or is in stage III.I have a tumor that can be surgically removed or sampled.My lung function tests are within normal limits.I haven't had cancer treatment or specific inhibitors in the last 4 weeks/7 days.You have a serious mental health condition that may affect your ability to understand the study or make immunotherapy unsafe for you.You have had a solid organ transplant.Your platelet count is at least 100,000 per cubic millimeter.I have a primary immune disorder but take less than 10 mg/day of prednisone.My immune system is functioning well after treatment, with no serious infections.I have had a bone marrow or stem cell transplant.I am currently taking strong cancer drugs and will be assessed for trial suitability.I have enough immune cells available for cancer treatment.I have small brain lesions, approved by my doctor for this treatment.I will use birth control for four months after starting treatment and throughout the study. I have a negative pregnancy test if applicable.I have used steroids recently or need to use them for my condition.You have enough infection-fighting white blood cells in your body.I can care for myself and am up and about more than 50% of my waking hours.I have had immunotherapy, targeted therapy, or no previous cancer treatment.I had a heart stress test within the last 6 months.Your liver enzyme level (ALT) is not more than three times the normal limit.I have a melanoma spot that can be biopsied and is at least 1 cm big.Your hemoglobin level is 8.0 grams per deciliter or higher.Your blood creatinine level is less than or equal to 1.6 mg/dl.Your total bilirubin level should be less than 2.0 mg/dl, unless you have Gilbert's syndrome, in which case it should be less than 3.0 mg/dl.
- Group 1: Treatment (chemotherapy, autologous T-cell immunotherapy)
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What medical purpose does TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes serve?
"Multiple sclerosis is often addressed with TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes. This therapeutic approach has demonstrated efficacy in treating other diseases, including acute myeloid leukemia, retinoblastoma, and histiocytic lymphoma."
What has the research revealed about TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes thus far?
"Currently, there are 874 active studies looking into the effects of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes. One hundred and fifty six of these trials have progressed to Phase 3. Despite the majority of research being conducted in Philadelphia, Pennsylvania, a total of 27051 sites around the world are currently running tests with this therapy."
What is the participant count of this investigation?
"Unfortunately, this trial is no longer enrolling members. The original listing was put up on October 15th 2014 and the most recent update occured December 10th 2020. If you are in search of other trials, there are 816 clinical studies currently seeking patients with stage iiib cutaneous melanoma and 874 research projects that require participants for TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes therapies."
To what extent could the utilization of TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes jeopardize patient safety?
"Due to the limited number of studies conducted on TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes and their safety, our team at Power has assigned it a score of 1."
Are there openings available for participants to join this experiment?
"This research study is not presently looking for participants. It was initially published on October 15th 2014, and the most recent update occurred in December 10th 2020. However, if you are hoping to join an active trial there are 816 studies actively recruiting those with stage iiib cutaneous melanoma and 874 trials searching for individuals interested in TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes."
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