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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

Must not have

Patients with unresectable lung metastases

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

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

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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.

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I have recovered from side effects of previous cancer treatments, except for hair loss and hearing loss.

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I have sarcoma, renal cell carcinoma, melanoma, or cancer that has spread beyond my lungs/thorax.

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My advanced cancer has spread to my lungs, but it can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung cancer cannot be removed with surgery.

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

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

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I am not pregnant, breastfeeding, and if I can have children, I agree to use effective birth control.

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I am currently on medication for breathing issues.

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I have moderate to severe symptoms like fever, cough, or difficulty breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03007238

30%

Anemia

20%

Sepsis

20%

Hyperglycemia

20%

Hypophosphatemia

20%

Dyspnea

20%

Hypertension

10%

Atrial flutter

10%

Bronchial infection

10%

Hyponatremia

10%

Anal pain

10%

CD4 lymphocytes decreased

10%

Nausea

10%

Oral pain

10%

Non-cardiac chest pain

10%

Catheter related infection

10%

Vascular access complication

10%

Alanine aminotransferase increased

10%

Pneumonitis

10%

Lymphocyte count decreased

10%

Platelet count decreased

10%

Hypokalemia

10%

Headache

10%

Anorexia

10%

Hypercalcemia

10%

Adult respiratory distress syndrome

10%

Hypotension

100%

80%

60%

40%

20%

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.

0 / 10Eligibility criteria met