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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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 has spread from the original tumor to the lungs. Biological therapies, such as aerosolized aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

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.

What data supports the effectiveness of the treatment Aerosolized Aldesleukin for lung cancer?

Aerosolized Aldesleukin, a form of interleukin-2 (IL-2), has shown promise in treating lung-related conditions by boosting the immune system locally in the lungs with fewer side effects compared to traditional methods. Studies have demonstrated its effectiveness in reducing lung metastases in animal models and its safety in early human trials, suggesting potential benefits for lung cancer treatment. ^{1 2 3 4 5}

Is Aerosolized Aldesleukin generally safe for humans?

Aldesleukin, also known as interleukin-2, has been used in cancer treatments but can cause serious side effects like low blood pressure and heart, lung, and kidney problems. These side effects are usually managed by stopping the treatment or using other medications, but some severe reactions have been reported, including a rare allergic reaction. ^{1 2 6 7 8}

How is the treatment Aerosolized Aldesleukin unique for lung cancer?

Aerosolized Aldesleukin is unique because it is delivered directly to the lungs as an inhaled mist, which allows for targeted immune system activation in the lungs with fewer side effects compared to traditional intravenous administration. This localized delivery can enhance the immune response against lung cancer while minimizing systemic toxicity. ^{1 2 3 4 9}

Research Team

Najat C. Daw

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand 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. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Aldesleukin (recombinant interleukin-2). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of inhaled natural interleukin 2 for treatment of pulmonary malignancy: toxicity, pharmacokinetics, and biological effects. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Interleukin-2: Old and New Approaches to Enhance Immune-Therapeutic Efficacy. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Effect of interleukin-6 on the growth of human lung cancer cell line. [2006]

6. England pubmed.ncbi.nlm.nih.gov

INBRX-120, a CD8α-targeted detuned IL-2 that selectively expands and activates tumoricidal effector cells for safe and durable in vivo responses. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Hypersensitivity to aldesleukin (interleukin-2 and proleukin) presenting as facial angioedema and erythema. [2016]

8. England pubmed.ncbi.nlm.nih.gov

TransCon IL-2 β/γ: a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Anti-tumor effects induced by fusion of interleukin-18 gene transfected NCI-H460 lung cancer cell line with dendritic cells]. [2007]