Clinical trial · Interventional
Aerosolized Aldesleukin in Treating Patients With Lung Metastases
Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases
NCT01590069CI-TRIAL-00108912active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Lung | — | UNRESOLVED | — |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Metastatic Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
| Metastatic Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Stage IV Cutaneous Melanoma AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IV Osteosarcoma AJCC v7 | Osteosarcoma | CURATED_BROADER | 0.78 |
| Stage IV Renal Cell Cancer AJCC v7 | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerosolized Aldesleukin | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (aerosolized aldesleukin)
- description
- Patients receive aerosolized aldesleukin QD on days 1-21. Courses repeat every 28 days in the absence of disease progression of unacceptable toxicity.
- interventionNames
- Biological: Aerosolized Aldesleukin
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- 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)
- timeFrame
- 28 days
- description
- The dose escalation will be conducted via the accelerated titration method for the first 2 dose levels.
- measure
- Incidence of adverse events (AE)s, using the CTCAE v4.0 (Phase II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.