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T Cell Immunotherapy for Lung Cancer
Study Summary
This trial is testing an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
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.Side effects data
From 2010 Phase 4 trial • 26 Patients • NCT00414765Trial Design
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Who is running the clinical trial?
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- You have a condition that weakens your immune system from birth.I am willing to use birth control during and after my treatment.I do not have any active infections, bleeding disorders, or serious illnesses.Your blood counts need to be within normal ranges: ANC (a type of white blood cell) should be higher than 1000, WBC (white blood cell) count should be higher than 2500, Hb (hemoglobin) should be higher than 8.0, and platelet count should be higher than 80,000.I am between 18 and 72 years old.You have an ongoing opportunistic infection.Your heart's pumping function (LVEF) is below 45%.You are currently taking any other experimental drugs.My lung cancer is advanced but has a part that can be removed for treatment.I have up to 3 small brain tumors (under 1 cm) that don't cause symptoms, or they've been treated and are stable.It has been over two weeks since I received treatment for major airway blockage or bleeding.I have finished all my previous cancer treatments.I am currently taking medication to suppress my immune system.I am over 66, have had more than 2 chest surgeries, or have poor exercise tolerance.I have a severe blockage or bleeding in my airways that can't be relieved.I am fully active or can carry out light work.Your liver and kidney function tests need to be within certain limits: ALT/AST levels in the blood should be no more than 2.5 times the normal range, creatinine levels should be no more than 1.6 mg/dl, and total bilirubin should be no more than 2 mg/dl (or 3 mg/dl if you have Gilbert's Syndrome).I have had at least one treatment for my condition and it has gotten worse.You do not have HIV, active hepatitis B, or hepatitis C.I am a woman who can have children and have a negative pregnancy test.If you have a history of lung problems, your FEV1 (a measure of lung function) is less than 50%.
- Group 1: 2/Low-Dose Aldesleukin
- Group 2: 1/High-Dose Aldesleukin
- 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
Does this experiment accept participants aged eighty-five and over?
"As outlined in the eligibility requirements, participants must fall between 18 and 70 years old. In addition to this trial, there are 435 medical studies specifically designed for individuals under the age of majority and 5458 trials focusing on those above senior citizen status."
To which primary ailments is Aldesleukin typically administered?
"Aldesleukin is typically prescribed for multiple sclerosis, but it has also been utilized to ameliorate leukemia, myelocytic acute, retinoblastoma and histiocytic lymphoma."
How many participants are currently included in this clinical experiment?
"Affirmative. The trial is actively recruiting as indicated by clinicaltrials.gov; the post was first published on October 23rd, 2014 and most recently updated on November 1st 2022. 85 patients are being sought from 2 locations for participation in this study."
Has the U.S. Food and Drug Administration given their stamp of approval to Aldesleukin?
"There is some evidence that Aldesleukin may be safe, so this medication has been assigned a score of 2. However, no data currently supports its efficacy in clinical trials."
Is there an ongoing call for participants to join this research program?
"Confirmed. The clinicaltrial.gov database shows that this medical trial, which was first advertised on October 23rd 2014, is still actively seeking participants. Currently 85 patients are needed from two different sites to complete the study."
What demographic is preferred for inclusion in this clinical experiment?
"This clinical study requires participants to have adenocarcinoma and be within the age range of 18-70. Currently, 85 applicants are being accepted into this trial."
What other studies have researchers conducted featuring Aldesleukin?
"At this point in time, there are 913 clinical studies running that focus on Aldesleukin. Of these trials, 163 of them are currently at Phase 3. Although the majority of trials for Aldesleukin take place in Philadelphia, Pennsylvania; 28673 locations worldwide can provide access to its treatments."
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