Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer
Background The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC). Methods Patients with nonresectable therapy‐refractory H...
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| Veröffentlicht in: | Head & neck 2014-07, Vol.36 (7), p.976-984 |
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| creator | Strieth, Sebastian Dunau, Christoph Michaelis, Uwe Jäger, Lorenz Gellrich, Donata Wollenberg, Barbara Dellian, Marc |
| description | Background
The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC).
Methods
Patients with nonresectable therapy‐refractory HNSCC were recruited for both ET treatment groups (3 or 4 patients per group). In cutaneous metastases, laser Doppler blood flow measurements were conducted during infusions.
Results
Only adverse events of grade 1 or 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE version 3.0) – in particular fatigue, chills, and hypertension – occurred. Follow‐up tumor volume measurements revealed stable disease in 4 of 5 cases. Reproducible dose‐dependent blood flow reductions in skin metastases during ET infusions provide evidence of biological effectiveness.
Conclusion
Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC. © 2013 Wiley Periodicals, Inc. Head Neck 36: 976–984, 2014 |
| doi_str_mv | 10.1002/hed.23397 |
| format | Article |
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The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC).
Methods
Patients with nonresectable therapy‐refractory HNSCC were recruited for both ET treatment groups (3 or 4 patients per group). In cutaneous metastases, laser Doppler blood flow measurements were conducted during infusions.
Results
Only adverse events of grade 1 or 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE version 3.0) – in particular fatigue, chills, and hypertension – occurred. Follow‐up tumor volume measurements revealed stable disease in 4 of 5 cases. Reproducible dose‐dependent blood flow reductions in skin metastases during ET infusions provide evidence of biological effectiveness.
Conclusion
Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC. © 2013 Wiley Periodicals, Inc. Head Neck 36: 976–984, 2014</description><identifier>ISSN: 1043-3074</identifier><identifier>EISSN: 1097-0347</identifier><identifier>DOI: 10.1002/hed.23397</identifier><identifier>PMID: 23733258</identifier><identifier>CODEN: HEANEE</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Aged ; Angiogenesis Inhibitors - administration & dosage ; Angiogenesis Inhibitors - adverse effects ; Carcinoma, Squamous Cell - blood supply ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - pathology ; Drug Delivery Systems ; EndoTAG-1 ; Female ; Fibrin Fibrinogen Degradation Products - analysis ; Head and Neck Neoplasms - blood supply ; Head and Neck Neoplasms - drug therapy ; Head and Neck Neoplasms - pathology ; HNSCC ; Humans ; Infusions, Intravenous ; laser Doppler blood flowmetry ; Laser-Doppler Flowmetry ; Leukocyte Count ; Lipopac ; Liposomes ; Male ; Middle Aged ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Platelet Count ; Prospective Studies ; Skin - blood supply ; Tumor Necrosis Factor-alpha - blood ; vascular disrupting agent</subject><ispartof>Head & neck, 2014-07, Vol.36 (7), p.976-984</ispartof><rights>Copyright © 2013 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3917-9b3a16a06fd1286a3657a88c24a33e3de6d11457deea53fa4de67f863df713323</citedby><cites>FETCH-LOGICAL-c3917-9b3a16a06fd1286a3657a88c24a33e3de6d11457deea53fa4de67f863df713323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhed.23397$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhed.23397$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,782,786,1419,27931,27932,45581,45582</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23733258$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Strieth, Sebastian</creatorcontrib><creatorcontrib>Dunau, Christoph</creatorcontrib><creatorcontrib>Michaelis, Uwe</creatorcontrib><creatorcontrib>Jäger, Lorenz</creatorcontrib><creatorcontrib>Gellrich, Donata</creatorcontrib><creatorcontrib>Wollenberg, Barbara</creatorcontrib><creatorcontrib>Dellian, Marc</creatorcontrib><title>Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer</title><title>Head & neck</title><addtitle>Head Neck</addtitle><description>Background
The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC).
Methods
Patients with nonresectable therapy‐refractory HNSCC were recruited for both ET treatment groups (3 or 4 patients per group). In cutaneous metastases, laser Doppler blood flow measurements were conducted during infusions.
Results
Only adverse events of grade 1 or 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE version 3.0) – in particular fatigue, chills, and hypertension – occurred. Follow‐up tumor volume measurements revealed stable disease in 4 of 5 cases. Reproducible dose‐dependent blood flow reductions in skin metastases during ET infusions provide evidence of biological effectiveness.
Conclusion
Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC. © 2013 Wiley Periodicals, Inc. Head Neck 36: 976–984, 2014</description><subject>Aged</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Angiogenesis Inhibitors - adverse effects</subject><subject>Carcinoma, Squamous Cell - blood supply</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Drug Delivery Systems</subject><subject>EndoTAG-1</subject><subject>Female</subject><subject>Fibrin Fibrinogen Degradation Products - analysis</subject><subject>Head and Neck Neoplasms - blood supply</subject><subject>Head and Neck Neoplasms - drug therapy</subject><subject>Head and Neck Neoplasms - pathology</subject><subject>HNSCC</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>laser Doppler blood flowmetry</subject><subject>Laser-Doppler Flowmetry</subject><subject>Leukocyte Count</subject><subject>Lipopac</subject><subject>Liposomes</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Platelet Count</subject><subject>Prospective Studies</subject><subject>Skin - blood supply</subject><subject>Tumor Necrosis Factor-alpha - blood</subject><subject>vascular disrupting agent</subject><issn>1043-3074</issn><issn>1097-0347</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kcFu1DAURSMEoqWw4AeQJTawSMfOS-LMEpXSmaoCJECws17tZyZtJk5tpzTfw4_idDoskFhYtq7OO7Z8s-yl4MeC82KxIXNcACzlo-xQ8KXMOZTy8XwuIQcuy4PsWQhXnHOoy-JpdlCABCiq5jD7_XmDgdh6sV4z3bV9q7FjIY5mYq5nAS3FiWFv0ortLQY9dugZWUs6BuYsGzCNRbyjjlGvcQgJiGRY2zONsXXJyLp2cMFtKTDrPIvof9KMxA15HKYZRXOLvU7ZhtDc39eTvk6GFPrn2ROLXaAXD_tR9u3D6deTVX7x6Wx98u4i17AUMl9eAooaeW2NKJoaoa4kNo0uSgQgMFQbIcpKGiKswGKZEmmbGoyVIn0HHGVvdt7Bu5uRQlTbNmjqOuzJjUGJCqSQUtQioa__Qa_c6Pv0upmqaiiXYha-3VHauxA8WTX4dot-UoKruTmVmlP3zSX21YNxvNymdE_uq0rAYgf8ajua_m9Sq9P3e2W-m2hDpLu_E-ivVS1BVur7xzP1oxLV6vwLqHP4A3oXsuc</recordid><startdate>201407</startdate><enddate>201407</enddate><creator>Strieth, Sebastian</creator><creator>Dunau, Christoph</creator><creator>Michaelis, Uwe</creator><creator>Jäger, Lorenz</creator><creator>Gellrich, Donata</creator><creator>Wollenberg, Barbara</creator><creator>Dellian, Marc</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7TK</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201407</creationdate><title>Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer</title><author>Strieth, Sebastian ; Dunau, Christoph ; Michaelis, Uwe ; Jäger, Lorenz ; Gellrich, Donata ; Wollenberg, Barbara ; Dellian, Marc</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3917-9b3a16a06fd1286a3657a88c24a33e3de6d11457deea53fa4de67f863df713323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Angiogenesis Inhibitors - administration & dosage</topic><topic>Angiogenesis Inhibitors - adverse effects</topic><topic>Carcinoma, Squamous Cell - blood supply</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Drug Delivery Systems</topic><topic>EndoTAG-1</topic><topic>Female</topic><topic>Fibrin Fibrinogen Degradation Products - analysis</topic><topic>Head and Neck Neoplasms - blood supply</topic><topic>Head and Neck Neoplasms - drug therapy</topic><topic>Head and Neck Neoplasms - pathology</topic><topic>HNSCC</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>laser Doppler blood flowmetry</topic><topic>Laser-Doppler Flowmetry</topic><topic>Leukocyte Count</topic><topic>Lipopac</topic><topic>Liposomes</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Platelet Count</topic><topic>Prospective Studies</topic><topic>Skin - blood supply</topic><topic>Tumor Necrosis Factor-alpha - blood</topic><topic>vascular disrupting agent</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Strieth, Sebastian</creatorcontrib><creatorcontrib>Dunau, Christoph</creatorcontrib><creatorcontrib>Michaelis, Uwe</creatorcontrib><creatorcontrib>Jäger, Lorenz</creatorcontrib><creatorcontrib>Gellrich, Donata</creatorcontrib><creatorcontrib>Wollenberg, Barbara</creatorcontrib><creatorcontrib>Dellian, Marc</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Head & neck</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Strieth, Sebastian</au><au>Dunau, Christoph</au><au>Michaelis, Uwe</au><au>Jäger, Lorenz</au><au>Gellrich, Donata</au><au>Wollenberg, Barbara</au><au>Dellian, Marc</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer</atitle><jtitle>Head & neck</jtitle><addtitle>Head Neck</addtitle><date>2014-07</date><risdate>2014</risdate><volume>36</volume><issue>7</issue><spage>976</spage><epage>984</epage><pages>976-984</pages><issn>1043-3074</issn><eissn>1097-0347</eissn><coden>HEANEE</coden><abstract>Background
The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC).
Methods
Patients with nonresectable therapy‐refractory HNSCC were recruited for both ET treatment groups (3 or 4 patients per group). In cutaneous metastases, laser Doppler blood flow measurements were conducted during infusions.
Results
Only adverse events of grade 1 or 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE version 3.0) – in particular fatigue, chills, and hypertension – occurred. Follow‐up tumor volume measurements revealed stable disease in 4 of 5 cases. Reproducible dose‐dependent blood flow reductions in skin metastases during ET infusions provide evidence of biological effectiveness.
Conclusion
Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC. © 2013 Wiley Periodicals, Inc. Head Neck 36: 976–984, 2014</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>23733258</pmid><doi>10.1002/hed.23397</doi><tpages>9</tpages></addata></record> |
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| ispartof | Head & neck, 2014-07, Vol.36 (7), p.976-984 |
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| subjects | Aged Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Carcinoma, Squamous Cell - blood supply Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology Drug Delivery Systems EndoTAG-1 Female Fibrin Fibrinogen Degradation Products - analysis Head and Neck Neoplasms - blood supply Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - pathology HNSCC Humans Infusions, Intravenous laser Doppler blood flowmetry Laser-Doppler Flowmetry Leukocyte Count Lipopac Liposomes Male Middle Aged Paclitaxel - administration & dosage Paclitaxel - adverse effects Platelet Count Prospective Studies Skin - blood supply Tumor Necrosis Factor-alpha - blood vascular disrupting agent |
| title | Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer |
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