Metastatic Malignant Neoplasm in the LungPhase 1/2NCT01590069
Aerosolized Aldesleukin in Treating Patients With Lung Metastases
A Phase 1/2 study testing Aerosolized Aldesleukin and Laboratory Biomarker Analysis in people with Metastatic Malignant Neoplasm in the Lung and Metastatic Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Lung, Metastatic Melanoma, Metastatic Osteosarcoma
- What is being tested?
- Aerosolized Aldesleukin and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2012to 30 Apr 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
- Creatinine =< 2 x upper limit of normal (ULN)
- Bilirubin =< 5 x ULN
- Aspartate aminotransferase (AST) =< 5 x ULN
- Forced vital capacity (FVC) >= 50% predicted
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- Oxygen (O2) saturation at rest >= 90% (off supplementary oxygen)
- 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
- No radiotherapy within 2 weeks: exception: patients may receive palliative low dose radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the treating physician; palliative radiotherapy could be given before aerosol treatment is started if necessary
- Subjects have to be able to read and understand English
- Patients with advanced cancer with resectable lung metastases
- Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease outside the lungs and/or thorax
Who cannot join
- Currently being treated with bronchodilators or corticosteroids
- Females: pregnant or breast feeding and if of child bearing potential (e.g. female of childbearing age that has not been amenorrheic for at least 12 consecutive month or surgically sterilized) not willing to use effective contraception
- 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
- Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
- Patients with unresectable lung metastases
- Patients without sarcoma, renal cell carcinoma, or melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate toxicity in patients with lung metastases during aerosol interleukin (IL)-2 (aldesleukin) therapy using self-report, remote spirometry and pulse oximetry.
SECONDARY OBJECTIVES:
- To determine dose and schedule of an acceptable aerosol IL-2 regimen and correlate with absolute lymphocyte count (ALC).
II. To determine serum IL-2 levels on day 1 of therapy for evidence of spillover into circulation and correlate with absence or presence of toxicity.
III. To evaluate the efficacy of aerosol IL-2 treatment using Response Evaluation Criteria in Solid Tumors (RECIST).
TERTIARY OBJECTIVES:
- To evaluate the histology in post-surgical specimens in patients who undergo surgery for lung metastases following aerosol IL-2 treatment as an optional procedure.
II. To evaluate immune correlates from optional pre-treatment biopsy and post-surgical specimen.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive aerosolized aldesleukin once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Metastatic Malignant Neoplasm in the Lung, Metastatic Melanoma, Metastatic Osteosarcoma, Metastatic Renal Cell Cancer, Sarcoma, Stage IV Cutaneous Melanoma AJCC v6 and v7
- Being tested
- Aerosolized Aldesleukin, Laboratory Biomarker Analysis
- Medical subject headings
- Melanoma, Osteosarcoma, Carcinoma, Renal Cell, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized AldesleukinBiological
Also called Aerosolized Recombinant IL-2
Breathe aerosolized aldesleukin
Laboratory Biomarker AnalysisOther
Optional correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (aerosolized aldesleukin) | Experimental | Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity. Receives: Biological: Aerosolized Aldesleukin; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The dose escalation will be conducted via the accelerated titration method for the first 2 dose levels.
Measured: 28 days
Incidence of adverse events (AE)s, using the CTCAE v4.0 (Phase II)
AEs will be summarized by severity according to the worst grade experienced over the number of patients at risk.
Measured: Up to 4 years
Response of measurable lesions to aerosol aldesleukin using modified RECIST (Phase II)
Response analysis will be performed on intent-to-treat, that is, any patient who enrolled into the expansion cohort. Patients who withdraw before the end of 2 months without responding will be considered non-responders. The two-sided 95% Clopper-Pearson confidence intervals will be calculated for the proportion of patients with responses.
Measured: Up to 4 years
Secondary outcomes (2)
IL-2 levels in serum
Serum IL-2 levels will be compared with maximum grade of toxicity to determine whether our hypothesis of "spillover" of IL-2 in the circulation - i.e. some escaping the receptor gauntlet of IL-2 receptor bearing cells in pulmonary lymphatics.
Measured: Day 1 of therapy
Changes in biomarker levels
Changes in biomarker levels between pre- and post-treatment tissue samples will be assessed using paired t-tests (if the data are normally distributed) or Wilcoxon signed-rank tests (otherwise). Will graph the data using histograms, box plots and dot plots. With 20 patients, using a 2-sided 5% alpha, there would be 80% power to detect an effect size of 0.66 (where the effect size is the mean difference divided by the standard deviation of the differences).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study start28 Jun 2012
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the LungStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Najat Daw, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590069
- Sponsor's protocol ID
- 2010-0700
- Other IDs
- NCI-2012-00788, 0700, 2010-0700
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2012
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No