Aerosolized Aldesleukin in Treating Patients With Lung Metastases

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Phase changed: Phase 1 → Phase 1/2
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Primary and study completion pushed from Apr 30, 2026 to Apr 30, 2029v32
  3. 2 versions Re-verified since Oct 24, 2025, no change to tracked fieldsv30-v31
  4. Study Identification, Study Status, Conditionsv29
  5. Study Identification, Study Status, Conditionsv28
Show 26 earlier versionsHide 26 earlier versions
  1. Primary and study completion dates: Apr 30, 2024 to Apr 30, 2026v27
  2. 2 versions Re-verified since Apr 11, 2023, no change to tracked fieldsv25-v26
  3. Primary and study completion dates: Dec 31, 2022 to Apr 30, 2024v24
  4. Re-verified, no change to tracked fieldsv23
  5. Primary completion date: Dec 31, 2021 to Dec 31, 2022v22
  6. Phase: Phase 1/2 to Phase 1
    • Primary completion date: Jun 30, 2020 to Dec 31, 2021
    • Study completion date: Jun 30, 2020 to Dec 31, 2022
    v21
  7. Re-verified, no change to tracked fieldsv20
  8. Primary and study completion dates: Jun 30, 2019 to Jun 30, 2020v19
  9. Primary endpoints: 2 to 3v18 Show 9 more changesShow less
    • Enrollment target: 56 to 70
    • Primary and study completion dates: Jun 2019 to Jun 30, 2019
    • Start date: Jun 2012 to Jun 28, 2012
    • Interventions: Aerosol IL-2 (Drug), Symptom Assessment (Procedure) to Aerosolized Aldesleukin (Biological), Laboratory Biomarker Analysis (Other)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints expanded, about 8 words
    • Study description shortened, about 610 words
    • Study site revised
    • Study title expanded, about 3 words
  10. Study description revisedv17
  11. Primary completion date: Jun 2018 to Jun 2019
    • Study completion date: Jun 2019
    v16
  12. Primary completion date: Jun 2017 to Jun 2018v15
  13. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborator revised
    v14
  14. Primary endpoints: 1 to 2
    • Study description shortened, about 61 words
    • Eligibility criteria expanded, about 4 words
    v13
  15. Primary completion date: Jun 2016 to Jun 2017
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 1 word
    v12
  16. Re-verified, no change to tracked fieldsv11
  17. Study site revised
    • Eligibility criteria expanded, about 1 word
    v10
  18. Study description shortened, about 24 words
    • Eligibility criteria expanded, about 5 words
    v9
  19. Eligibility criteria shortened, about 7 words
    • Study description expanded, about 8 words
    v8
  20. Re-verified, no change to tracked fieldsv7
  21. Eligibility criteria shortened, about 33 wordsv6
  22. Study description expanded, about 147 words
    • Eligibility criteria shortened, about 5 words
    v5
  23. Eligibility criteria shortened, about 13 wordsv4
  24. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Oct 2016 to Jun 2016
    • Start date: Oct 2012 to Jun 2012
    • Eligibility criteria expanded, about 13 words
    • Site details revised
  25. Study description expanded, about 1 wordv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
M.D. Anderson Cancer Center
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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 Details
NCT Number NCT01590069
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Malignant Neoplasm in the Lung, Metastatic Melanoma, Metastatic Osteosarcoma, Metastatic Renal Cell Cancer, Sarcoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Osteosarcoma AJCC v7, Stage IV Renal Cell Cancer AJCC v7
Related terms Carcinoma, Renal Cell, Melanoma, Osteosarcoma, Sarcoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov