Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Phase 1
Active, not recruiting
NCT03228537
| Condition | Biphasic Mesothelioma, Epithelioid Mesothelioma, Stage I Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage IA Pleural Diffuse Malignant Mesothelioma AJCC v7 |
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| Phase | Phase 1 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 28 participants |
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| Interventions | Atezolizumab, Cisplatin, Extrapleural Pneumonectomy, Pemetrexed Disodium, Pleurectomy |
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| Start date | Jul 16, 2018 |
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| Completion date | Oct 1, 2022 |
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| Results posted | Mar 5, 2024 |
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Summary
This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy works in treating patients with stage I-III pleural malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.
Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
Duration of treatment until first dose of maintenance therapy. Includes 21 day cycles of neoadjuvant chemo and surgery - extrapleural pneumonectomy or pleurectomy/decortication (radiation therapy for participants who received extrapleural pneumonectomy). · Participants
| Treatment (Chemotherapy, Surgery +/- RT, Maintenance) | 15 Participants |
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Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
Duration of treatment and follow-up until death or 3 years post Step 1 registration. · Participants
| Treatment (Chemotherapy, Surgery +/- RT, Maintenance) | 1 Participants |
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Open in BENITIONS
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