Aerosolized Aldesleukin for Lung Cancer

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Bronchodilators, Corticosteroids

Disqualifiers: Pregnancy, Uncontrolled illness, Fever, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 28 days per course

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals whose cancer has spread to their lungs. The focus is on aerosolized aldesleukin, a therapy designed to help the immune system fight cancer by preventing tumor growth. Participants will receive the treatment daily for three weeks, followed by a week off before repeating the cycle. This trial may suit those with advanced cancer, particularly if they have sarcoma, renal cell carcinoma, or melanoma, and their cancer has spread to their lungs. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently being treated with bronchodilators or corticosteroids.

Is there any evidence suggesting that aerosolized aldesleukin is likely to be safe for humans?

Research has shown that a new treatment called aerosolized aldesleukin is being tested for safety in people with lung-related cancers. Early results suggest that this treatment is generally safe when inhaled as a mist. Tested in individuals aged 12 and older, these studies have reported no serious side effects so far.

Some participants have experienced mild to moderate side effects, which are common in early treatment trials. These side effects can include coughing or minor breathing issues due to the inhalation method. It's important to know that these studies are still in the early stages, focusing on ensuring the treatment's safety. Therefore, researchers are carefully monitoring for any unwanted effects.

Overall, while the treatment looks promising, research continues to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about aerosolized aldesleukin for lung cancer because it offers a novel delivery method that directly targets the lungs. Unlike standard treatments like chemotherapy and radiation, which can affect the entire body, aerosolized aldesleukin is inhaled, potentially concentrating its effects in the lungs and reducing systemic side effects. Additionally, aldesleukin is a form of interleukin-2, an immune system booster, which might help the body fight cancer more effectively from within. This approach could enhance the immune system's ability to target and destroy cancer cells, offering a promising new avenue for lung cancer treatment.

What evidence suggests that aerosolized aldesleukin might be an effective treatment for lung cancer?

Research has shown that aerosolized aldesleukin, a protein that boosts the immune system, may help treat certain cancers. Studies have found that this treatment can strengthen the body's natural killer cells, which are crucial for fighting cancer, especially when it spreads to the lungs. Specifically, research demonstrated that aerosolized aldesleukin enhanced natural killer cell therapy in a lung cancer model without causing serious side effects. Additionally, aldesleukin has proven effective in treating kidney cancer, with significant response rates. These findings suggest that aerosolized aldesleukin might help control tumor growth in patients whose cancer has spread to the lungs. ^{4 5 6 7 8}

Who Is on the Research Team?

Najat C. Daw

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Your oxygen level at rest is 90% or higher without using extra oxygen.

I have advanced cancer with lung metastases and haven't received prior therapy because there's no better treatment available.

Exclusion Criteria

My lung cancer cannot be removed with surgery.

I do not have any serious illnesses that could interfere with the study.

I do not have sarcoma, renal cell carcinoma, or melanoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive aerosolized aldesleukin once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per course

Daily visits for 21 days per course

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days

Long-term follow-up

Participants are monitored for adverse events and response of measurable lesions using modified RECIST

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Aerosolized Aldesleukin

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (aerosolized aldesleukin) Experimental Treatment 2 Interventions

Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Aldesleukin, a treatment for metastatic renal cell carcinoma and melanoma, has been associated with severe systemic toxicity, which has limited its use.

This study reports the first confirmed case of an immediate systemic hypersensitivity reaction to aldesleukin, identified through specific immunoglobulin E testing, highlighting a previously unrecognized safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypersensitivity to aldesleukin (interleukin-2 and proleukin) presenting as facial angioedema and erythema. Abraham, D., McGrath, KG.[2016]

Aldesleukin (recombinant interleukin-2) has shown efficacy in treating renal cell carcinoma, with response rates of 13-20% for intravenous and 18-31% for subcutaneous administration, which are higher than the approximately 10% response rates of other treatments.

While aldesleukin can lead to serious side effects, particularly with bolus intravenous administration, the severity of these adverse events is reduced with continuous infusion or subcutaneous administration, making it a potentially safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aldesleukin (recombinant interleukin-2): a review of its pharmacological properties, clinical efficacy and tolerability in patients with renal cell carcinoma. Jeal, W., Goa, KL.[2018]

Aldesleukin (recombinant IL-2) has shown modest efficacy in treating metastatic melanoma, with response rates up to 56% in combination therapies, but median survival times remain around 10 to 11 months, indicating limited long-term benefits.

The administration methods of aldesleukin have evolved to reduce toxicity, with continuous intravenous infusion and subcutaneous options leading to fewer severe adverse events, but further studies are needed to fully understand its risk/benefit profile compared to standard chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aldesleukin (recombinant interleukin-2). Noble, S., Goa, KL.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01590069

Aerosolized Aldesleukin in Treating Patients With Lung ... This phase I/II trial studies the side effects and best dose of aerosolized aldesleukin and to see how well it works in treating patients with cancer that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4154381/

NATURAL KILLER CELL THERAPY AND AEROSOL ... CONCLUSION. Aerosol IL-2 augmented the efficacy of NK cell therapy against osteosarcoma lung metastasis, without inducing systemic toxicity. Our data suggest ...

3. aacrjournals.org aacrjournals.org/cancerres/article/74/19_Supplement/CT406/598450/Abstract-CT406-Aerosol-interleukin-2-for-the

Aerosol interleukin-2 for the treatment of patients ≥ 12 years ... OS survival has remained at 65-70% for the last 20 years. Our pre-clinical data using a human OS mouse model demonstrated therapeutic efficacy ...

4. withpower.com withpower.com/trial/phase-1-neoplasms-5-2012-caee3

Aerosolized Aldesleukin for Lung Cancer Aldesleukin (recombinant interleukin-2) has shown efficacy in treating renal cell carcinoma, with response rates of 13-20% for intravenous and 18-31% for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01590069?cond=%22Bone%20Cancer%22&intr=%22interleukin-2%22&viewType=Table&rank=3

Study Details | Aerosolized Aldesleukin in Treating Patients ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01590069?term=aldesleukin&draw=2&rank=7

Aerosolized Aldesleukin in Treating Patients With Lung ... This phase I/II trial studies the side effects and best dose of aerosolized aldesleukin and to see how well it works in treating patients with cancer that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3991292/

Evaluation of aerosol IL-2 in sarcoma patients with lung ... Since sarcoma metastasizes to the lung, aerosol delivery is a reasonable approach. The study is to determine the safety of aerosol IL-2 in patients > 12 yrs.

8. aacrjournals.org aacrjournals.org/cancerres/article/74/20_Supplement/A82/598999/Abstract-A82-Feasibility-and-safety-of-aerosol-IL

Abstract A82: Feasibility and safety of aerosol IL-2 in patients ... The purpose of this study is to evaluate safety of aerosol IL-2 in patients > 12 yrs. with lung metastases to establish the maximum tolerated ...