Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment : A Phase 1, Open-Label, Dose-Escalation, Multiple Dose Study of the Safety, Tolerability, and Immune Response of CRS-207 in Adult Subjects With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment
This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer. The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level..
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Klinische Studie| Erscheinungsjahr: |
2009 |
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| Erschienen: |
2009 |
| Enthalten in: |
ClinicalTrials.gov - (2009) vom: 20. Feb. Zur Gesamtaufnahme - year:2009 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 3, 2008, Last downloaded: ClinicalTrials.gov processed this data on June 14, 2021, Last updated: June 15, 2021 |
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| Study ID: |
NCT00585845 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000484415 |
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| 245 | 1 | 0 | |a Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment |b A Phase 1, Open-Label, Dose-Escalation, Multiple Dose Study of the Safety, Tolerability, and Immune Response of CRS-207 in Adult Subjects With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: January 3, 2008, Last downloaded: ClinicalTrials.gov processed this data on June 14, 2021, Last updated: June 15, 2021 | ||
| 520 | |a This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer. The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level. | ||
| 650 | 2 | |a Adenocarcinoma | |
| 650 | 2 | |a Mesothelioma | |
| 650 | 2 | |a Carcinoma, Non-Small-Cell Lung | |
| 650 | 4 | |a Medical Condition: Malignant Epithelial Mesothelioma, Adenocarcinoma of the Pancreas, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of the Ovaries | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
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