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Cytokine
Aerosolized Aldesleukin for Lung Cancer
Phase 1
Waitlist Available
Led By Najat Daw
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 for ages >= 16 or Lansky play >= 80% for ages =< 15
Patients must have recovered to =< grade 1 toxicity (except alopecia and hearing loss) from any prior chemotherapy, other investigational therapy, hormonal, biological, targeted agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of a drug that may help the immune system fight cancer that has spread to the lungs.
Who is the study for?
This trial is for patients with advanced cancer that has spread to the lungs, including those with sarcoma, renal cell carcinoma, or melanoma. Participants must be in good physical condition (ECOG <=1), have acceptable organ function tests, and not be on certain medications like bronchodilators or corticosteroids. Pregnant women and those not using contraception are excluded.Check my eligibility
What is being tested?
The trial is testing aerosolized Aldesleukin to determine its safety and optimal dosage for treating lung metastases from various cancers. It's a phase I/II study which means they're looking at how well it works after confirming it's safe.See study design
What are the potential side effects?
Potential side effects of aerosolized Aldesleukin may include immune system reactions that could lead to inflammation, difficulty breathing due to lung irritation, fatigue, coughing or wheezing if the treatment affects normal lung function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 or older and can carry out all my self-care activities without help, or I am 15 or younger and can do most activities normally.
Select...
I have recovered from side effects of previous cancer treatments, except for hair loss and hearing loss.
Select...
I have sarcoma, renal cell carcinoma, melanoma, or cancer that has spread beyond my lungs/thorax.
Select...
My advanced cancer has spread to my lungs, but it can be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AE)s, using the CTCAE v4.0 (Phase II)
Maximum tolerated dose, defined as the highest dose level with six patients with at most one dose limiting toxicity, using the CTCAE v4.0 (Phase I)
Response of measurable lesions to aerosol aldesleukin using modified RECIST (Phase II)
Secondary outcome measures
Changes in biomarker levels
IL-2 levels in serum
Side effects data
From 2019 Phase 2 trial • 10 Patients • NCT0300723830%
Anemia
20%
Sepsis
20%
Hypertension
20%
Hypophosphatemia
20%
Hyperglycemia
20%
Dyspnea
10%
Bronchial infection
10%
Pneumonitis
10%
Hypotension
10%
Catheter related infection
10%
Hypokalemia
10%
Headache
10%
Anal pain
10%
Anorexia
10%
Oral pain
10%
CD4 lymphocytes decreased
10%
Alanine aminotransferase increased
10%
Lymphocyte count decreased
10%
Nausea
10%
Non-cardiac chest pain
10%
Hypercalcemia
10%
Vascular access complication
10%
Adult respiratory distress syndrome
10%
Atrial flutter
10%
Platelet count decreased
10%
Hyponatremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (aerosolized aldesleukin)Experimental Treatment2 Interventions
Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,732 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,597 Total Patients Enrolled
Najat DawPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer cannot be removed with surgery.I am 16 or older and can carry out all my self-care activities without help, or I am 15 or younger and can do most activities normally.I do not have any serious illnesses that could interfere with the study.Your oxygen level at rest is 90% or higher without using extra oxygen.I do not have sarcoma, renal cell carcinoma, or melanoma.I have advanced cancer with lung metastases and haven't received prior therapy because there's no better treatment available.I have recovered from side effects of previous cancer treatments, except for hair loss and hearing loss.I am willing to follow the study's treatment plan and safety checks.I have sarcoma, renal cell carcinoma, melanoma, or cancer that has spread beyond my lungs/thorax.I am not pregnant, breastfeeding, and if I can have children, I agree to use effective birth control.My advanced cancer has spread to my lungs, but it can be surgically removed.I am currently on medication for breathing issues.I haven't had radiotherapy in the last 2 weeks, except for low dose palliative care.I have moderate to severe symptoms like fever, cough, or difficulty breathing.Your bilirubin levels in the blood should be less than 5 times the upper limit of normal.Your creatinine level is not more than twice the normal limit.Your AST levels are not more than 5 times the normal upper limit.You can breathe out a certain amount of air, at least half of what is expected for someone your age and size.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (aerosolized aldesleukin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research recruiting people aged 45 or older?
"Patients between the ages of 12 and 50 can qualify to participate in this research. There are also 509 studies available for people under 18, as well as 3497 trials designated specifically for those over 65 years old."
Answered by AI
Are there vacancies for this experiment that participants can fill?
"As per the clinicaltrials.gov listing, this medical trial is not currently seeking participants and has been inactive since October 11th 2022; however there are an abundance of other trials actively recruiting individuals at this moment in time."
Answered by AI
How many participants have been recruited for this trial?
"This specific medical study is no longer recruiting patients. Initially posted on June 28th 2012 and last updated October 11, 2022, it has been concluded. However, there are still 3707 studies involving sarcoma looking for participants and 58 trials utilizing Aerosolized Aldesleukin searching for individuals to take part in their research."
Answered by AI
Has the Federal Drug Administration (FDA) sanctioned aerosolized aldesleukin for use?
"The safety of aerosolized aldesleukin has been assessed to be 1 on the scale from 1 to 3, as it is currently in its first trial and there is very limited evidence for both its efficacy and safety."
Answered by AI
Could you please provide an overview of other experiments that have utilized Aerosolized Aldesleukin?
"Currently, 58 Aerosolized Aldesleukin studies are underway with 4 of them in their terminal Phase 3. Boston is the main hub for these treatments but 396 trial sites across America have signed up to conduct research on this medication."
Answered by AI
Who is eligible for participation in this clinical experiment?
"To be accepted into this trial, patients must have sarcoma and fall between the ages of 12 and 50. Altogether, 70 people are being sought for recruitment."
Answered by AI
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