Aerosolized Aldesleukin in Treating Patients With Lung Metastases
Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases
3 other identifiers
interventional
70
1 country
1
Brief 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. Biological therapies, such as aerosolized aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedStudy Start
First participant enrolled
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
April 16, 2026
April 1, 2026
13.8 years
April 30, 2012
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Up to 4 years
Secondary Outcomes (2)
IL-2 levels in serum
Day 1 of therapy
Changes in biomarker levels
Baseline to 8 weeks
Study Arms (1)
Treatment (aerosolized aldesleukin)
EXPERIMENTALPatients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.
Interventions
Breathe aerosolized aldesleukin
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Najat Daw
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 2, 2012
Study Start
June 28, 2012
Primary Completion (Estimated)
April 30, 2026
Study Completion (Estimated)
April 30, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04