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NCT01590069
Aerosolized Aldesleukin in Treating Patients With Lung Metastases
Phase 1 trial testing Aerosolized Aldesleukin in Metastatic Malignant Neoplasm in the Lung in 70 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 28 June 2012 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aerosolized Aldesleukin — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
Conditions studied
- Metastatic Malignant Neoplasm in the Lung — all drugs for Metastatic Malignant Neoplasm in the Lung →
- Metastatic Melanoma — all drugs for Metastatic Melanoma →
- Metastatic Osteosarcoma — all drugs for Metastatic Osteosarcoma →
- Metastatic Renal Cell Cancer — all drugs for Metastatic Renal Cell Cancer →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 12 to 50, any sex, with Metastatic Malignant Neoplasm in the Lung or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pulmonary Delivery of Biological Drugs.
Liang W, Pan HW, Vllasaliu D, Lam JKW. · · 2020 · cited 115× · PMID 33114726 · DOI 10.3390/pharmaceutics12111025 -
Recent and Ongoing Research into Metastatic Osteosarcoma Treatments.
Harris MA, Hawkins CJ. · · 2022 · cited 100× · PMID 35409176 · DOI 10.3390/ijms23073817 -
Present Advances and Future Perspectives of Molecular Targeted Therapy for Osteosarcoma.
Shaikh AB, Li F, Li M, He B, et al · · 2016 · cited 89× · PMID 27058531 · DOI 10.3390/ijms17040506 -
Developing inhaled protein therapeutics for lung diseases.
Matthews AA, Ee PLR, Ge R. · · 2020 · cited 57× · PMID 34765995 · DOI 10.1186/s43556-020-00014-z -
Trial Watch: Immunostimulatory cytokines.
Vacchelli E, Eggermont A, Fridman WH, Galon J, et al · · 2013 · cited 47× · PMID 24073369 · DOI 10.4161/onci.24850 -
Bone Sarcomas in Pediatrics: Progress in Our Understanding of Tumor Biology and Implications for Therapy.
Rivera-Valentin RK, Zhu L, Hughes DP. · · 2015 · cited 31× · PMID 26002157 · DOI 10.1007/s40272-015-0134-4 -
Molecular mechanisms of osteosarcoma metastasis and possible treatment opportunities.
Du X, Wei H, Zhang B, Wang B, et al · · 2023 · cited 23× · PMID 37197432 · DOI 10.3389/fonc.2023.1117867 -
Enhancing Natural Killer Cell Targeting of Pediatric Sarcoma.
Omer N, Nicholls W, Ruegg B, Souza-Fonseca-Guimaraes F, et al · · 2021 · cited 18× · PMID 34804076 · DOI 10.3389/fimmu.2021.791206
Verify or expand the search:
- PubMed search for NCT01590069
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01590069 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01590069.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing