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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 with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be required
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 below
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 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.
My advanced cancer has spread to my lungs, but it can be surgically removed.
I haven't had radiotherapy in the last 2 weeks, except for low dose palliative care.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

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

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
2,964 Previous Clinical Trials
1,804,348 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,635 Previous Clinical Trials
40,929,503 Total Patients Enrolled
Najat DawPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

Aerosolized Aldesleukin (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT01590069 — Phase 1
Renal Cell Carcinoma Research Study Groups: Treatment (aerosolized aldesleukin)
Renal Cell Carcinoma Clinical Trial 2023: Aerosolized Aldesleukin Highlights & Side Effects. Trial Name: NCT01590069 — Phase 1
Aerosolized Aldesleukin (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01590069 — Phase 1

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
~0 spots leftby Apr 2024