Phase I Trial of Combined Immunotherapy with Subcutaneous Granulocyte Macrophage Colony-stimulating Factor, Low-Dose Interleukin 2, and Interferon α in Progressive Metastatic Melanoma and Renal Cell Carcinoma
The purpose of our study was to determine the maximally tolerated dose (MTD) and DLT of combined administration of granulocyte macrophage colony-stimulating factor (GM-CSF), low-dose interleukin 2 (IL-2) and IFN-α in patients with progressive metastatic melanoma or renal cell carcinoma (RCC). In add...
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| creator | de Gast, G C Klümpen, H J Vyth-Dreese, F A Kersten, M J Verra, N C Sein, J Batchelor, D Nooijen, W J Schornagel, J H |
| description | The purpose
of our study was to determine the maximally tolerated dose (MTD) and
DLT of combined administration of granulocyte macrophage
colony-stimulating factor (GM-CSF), low-dose interleukin 2 (IL-2) and
IFN-α in patients with progressive metastatic melanoma or renal cell
carcinoma (RCC). In addition, the activation and expansion of effector
cells were measured. Cohorts of three patients were treated with
increasing doses of IL-2 (1, 4, and 8 MIU/m 2 ) and GM-CSF
(2.5 and 5 μg/kg) with a constant dose of IFNα (5 million
units) s.c. for 12 days every 3 weeks. An additional six
patients were treated at the MTD. Immune activation was monitored
during the first cycle. Response was evaluated after two cycles. The
MTD was found to be 2.5 μg/kg GM-CSF, 4 MIU/m 2 IL-2, and
5 mega units of IFNα. DLT was grade 4 fever, chills with hypotension,
grade 3 fatigue/malaise, and fluid retention. Dose reduction of
IL-2 to 2 MIU/m 2 was necessary in three of nine patients
who initially received the MTD. Treatment was initiated in the hospital
but could be continued at home after 3–4 days. Significant increases
in lymphocytes, (activated) T cells (CD4+ and CD8+), NK cells,
monocyte DR expression, neutrophils, and eosinophils were found.
CD8+ T-cell activation (sCD8) and NK cell expansion was mainly
present in patients receiving 2 or 4 MIU/m 2 IL-2. Of eight
patients with progressive metastatic RCC after nephrectomy, three
achieved a complete remission, and 1 of 7 patients with metastatic
melanoma achieved a partial remission. In our study, the MTD of
combined immunotherapy with GM-CSF, IL-2, and IFNα was established;
DLT was: ( a ) grade 4 fever with hypotension needing i.v.
fluid support; and ( b ) grade 3 fluid retention and/or
fatigue/malaise. The scheme resulted in considerable expansion
and/or activation of various effector cells. The complete responses in
RCC patients are promising but need to be confirmed in Phase II
studies. |
| format | Article |
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of our study was to determine the maximally tolerated dose (MTD) and
DLT of combined administration of granulocyte macrophage
colony-stimulating factor (GM-CSF), low-dose interleukin 2 (IL-2) and
IFN-α in patients with progressive metastatic melanoma or renal cell
carcinoma (RCC). In addition, the activation and expansion of effector
cells were measured. Cohorts of three patients were treated with
increasing doses of IL-2 (1, 4, and 8 MIU/m 2 ) and GM-CSF
(2.5 and 5 μg/kg) with a constant dose of IFNα (5 million
units) s.c. for 12 days every 3 weeks. An additional six
patients were treated at the MTD. Immune activation was monitored
during the first cycle. Response was evaluated after two cycles. The
MTD was found to be 2.5 μg/kg GM-CSF, 4 MIU/m 2 IL-2, and
5 mega units of IFNα. DLT was grade 4 fever, chills with hypotension,
grade 3 fatigue/malaise, and fluid retention. Dose reduction of
IL-2 to 2 MIU/m 2 was necessary in three of nine patients
who initially received the MTD. Treatment was initiated in the hospital
but could be continued at home after 3–4 days. Significant increases
in lymphocytes, (activated) T cells (CD4+ and CD8+), NK cells,
monocyte DR expression, neutrophils, and eosinophils were found.
CD8+ T-cell activation (sCD8) and NK cell expansion was mainly
present in patients receiving 2 or 4 MIU/m 2 IL-2. Of eight
patients with progressive metastatic RCC after nephrectomy, three
achieved a complete remission, and 1 of 7 patients with metastatic
melanoma achieved a partial remission. In our study, the MTD of
combined immunotherapy with GM-CSF, IL-2, and IFNα was established;
DLT was: ( a ) grade 4 fever with hypotension needing i.v.
fluid support; and ( b ) grade 3 fluid retention and/or
fatigue/malaise. The scheme resulted in considerable expansion
and/or activation of various effector cells. The complete responses in
RCC patients are promising but need to be confirmed in Phase II
studies.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>PMID: 10778950</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Carcinoma, Renal Cell - drug therapy ; Carcinoma, Renal Cell - immunology ; CD8 Antigens - blood ; CD8 Antigens - drug effects ; Cytokines - blood ; Cytokines - drug effects ; Dose-Response Relationship, Drug ; Fatigue - chemically induced ; Female ; Fever - chemically induced ; Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage ; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects ; Humans ; Immunotherapy ; Injections, Subcutaneous ; Interferon-alpha - administration & dosage ; Interferon-alpha - adverse effects ; Interleukin-2 - administration & dosage ; Interleukin-2 - adverse effects ; Kidney Neoplasms - drug therapy ; Kidney Neoplasms - immunology ; Killer Cells, Natural - cytology ; Killer Cells, Natural - drug effects ; Killer Cells, Natural - immunology ; Lymphocyte Count - drug effects ; Male ; Medical sciences ; Melanoma - drug therapy ; Melanoma - immunology ; Middle Aged ; Neoplasm Metastasis ; Pharmacology. Drug treatments ; Receptors, Interleukin-2 - blood ; Receptors, Interleukin-2 - drug effects ; T-Lymphocytes - cytology ; T-Lymphocytes - drug effects ; T-Lymphocytes - immunology ; Treatment Outcome ; Weight Gain - drug effects</subject><ispartof>Clinical cancer research, 2000-04, Vol.6 (4), p.1267-1272</ispartof><rights>2000 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1361629$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10778950$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Gast, G C</creatorcontrib><creatorcontrib>Klümpen, H J</creatorcontrib><creatorcontrib>Vyth-Dreese, F A</creatorcontrib><creatorcontrib>Kersten, M J</creatorcontrib><creatorcontrib>Verra, N C</creatorcontrib><creatorcontrib>Sein, J</creatorcontrib><creatorcontrib>Batchelor, D</creatorcontrib><creatorcontrib>Nooijen, W J</creatorcontrib><creatorcontrib>Schornagel, J H</creatorcontrib><title>Phase I Trial of Combined Immunotherapy with Subcutaneous Granulocyte Macrophage Colony-stimulating Factor, Low-Dose Interleukin 2, and Interferon α in Progressive Metastatic Melanoma and Renal Cell Carcinoma</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>The purpose
of our study was to determine the maximally tolerated dose (MTD) and
DLT of combined administration of granulocyte macrophage
colony-stimulating factor (GM-CSF), low-dose interleukin 2 (IL-2) and
IFN-α in patients with progressive metastatic melanoma or renal cell
carcinoma (RCC). In addition, the activation and expansion of effector
cells were measured. Cohorts of three patients were treated with
increasing doses of IL-2 (1, 4, and 8 MIU/m 2 ) and GM-CSF
(2.5 and 5 μg/kg) with a constant dose of IFNα (5 million
units) s.c. for 12 days every 3 weeks. An additional six
patients were treated at the MTD. Immune activation was monitored
during the first cycle. Response was evaluated after two cycles. The
MTD was found to be 2.5 μg/kg GM-CSF, 4 MIU/m 2 IL-2, and
5 mega units of IFNα. DLT was grade 4 fever, chills with hypotension,
grade 3 fatigue/malaise, and fluid retention. Dose reduction of
IL-2 to 2 MIU/m 2 was necessary in three of nine patients
who initially received the MTD. Treatment was initiated in the hospital
but could be continued at home after 3–4 days. Significant increases
in lymphocytes, (activated) T cells (CD4+ and CD8+), NK cells,
monocyte DR expression, neutrophils, and eosinophils were found.
CD8+ T-cell activation (sCD8) and NK cell expansion was mainly
present in patients receiving 2 or 4 MIU/m 2 IL-2. Of eight
patients with progressive metastatic RCC after nephrectomy, three
achieved a complete remission, and 1 of 7 patients with metastatic
melanoma achieved a partial remission. In our study, the MTD of
combined immunotherapy with GM-CSF, IL-2, and IFNα was established;
DLT was: ( a ) grade 4 fever with hypotension needing i.v.
fluid support; and ( b ) grade 3 fluid retention and/or
fatigue/malaise. The scheme resulted in considerable expansion
and/or activation of various effector cells. The complete responses in
RCC patients are promising but need to be confirmed in Phase II
studies.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Renal Cell - drug therapy</subject><subject>Carcinoma, Renal Cell - immunology</subject><subject>CD8 Antigens - blood</subject><subject>CD8 Antigens - drug effects</subject><subject>Cytokines - blood</subject><subject>Cytokines - drug effects</subject><subject>Dose-Response Relationship, Drug</subject><subject>Fatigue - chemically induced</subject><subject>Female</subject><subject>Fever - chemically induced</subject><subject>Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage</subject><subject>Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Injections, Subcutaneous</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - adverse effects</subject><subject>Interleukin-2 - administration & dosage</subject><subject>Interleukin-2 - adverse effects</subject><subject>Kidney Neoplasms - drug therapy</subject><subject>Kidney Neoplasms - immunology</subject><subject>Killer Cells, Natural - cytology</subject><subject>Killer Cells, Natural - drug effects</subject><subject>Killer Cells, Natural - immunology</subject><subject>Lymphocyte Count - drug effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Melanoma - drug therapy</subject><subject>Melanoma - immunology</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Pharmacology. Drug treatments</subject><subject>Receptors, Interleukin-2 - blood</subject><subject>Receptors, Interleukin-2 - drug effects</subject><subject>T-Lymphocytes - cytology</subject><subject>T-Lymphocytes - drug effects</subject><subject>T-Lymphocytes - immunology</subject><subject>Treatment Outcome</subject><subject>Weight Gain - drug effects</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkM1u1DAQxyMEoqXwCsgHJC6NZDuOkz2ihZaVFlFBOUdjZ7wxOPbKdrrax-qLIPFGuGwrLjOjmd_85-NZdc7atqsbLtvnJaZdX1PR8LPqVUo_KWWCUfGyOiuFrl-19Lz6czNBQrIht9GCI8GQdZiV9TiSzTwvPuQJI-yP5GDzRL4vSi8ZPIYlkesIfnFBHzOSL6Bj2E-ww9Lvgj_WKdt5cZCt35Er0DnES7INh_pjeBjnM0aHyy_rCb8k4MdTymAMnvy-JyV_E8MuYkr2rshjhpSLmC6hAx9m-Nf0DX1Zeo2uGIjaPhReVy8MuIRvHv1F9ePq0-36c739er1Zf9jWE5d9rnttAFroVavYaHinejqi0UYJJqhWLRUriaxXiqtemm41MiE56IZKIY2mTXNRvT3p7hc14zjso50hHoen3xbg3SMASYMz5V3apv9cI5nkq4K9P2GT3U0HG3HQBcRYbsdy0zTIQQyMy675C7k_ltM</recordid><startdate>20000401</startdate><enddate>20000401</enddate><creator>de Gast, G C</creator><creator>Klümpen, H J</creator><creator>Vyth-Dreese, F A</creator><creator>Kersten, M J</creator><creator>Verra, N C</creator><creator>Sein, J</creator><creator>Batchelor, D</creator><creator>Nooijen, W J</creator><creator>Schornagel, J H</creator><general>American Association for Cancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>20000401</creationdate><title>Phase I Trial of Combined Immunotherapy with Subcutaneous Granulocyte Macrophage Colony-stimulating Factor, Low-Dose Interleukin 2, and Interferon α in Progressive Metastatic Melanoma and Renal Cell Carcinoma</title><author>de Gast, G C ; Klümpen, H J ; Vyth-Dreese, F A ; Kersten, M J ; Verra, N C ; Sein, J ; Batchelor, D ; Nooijen, W J ; Schornagel, J H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h268t-8cfaa5a8b5b1df27b80defcfb4140cb50496e18bb2b86f79d1462ac30646fc033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Carcinoma, Renal Cell - drug therapy</topic><topic>Carcinoma, Renal Cell - immunology</topic><topic>CD8 Antigens - blood</topic><topic>CD8 Antigens - drug effects</topic><topic>Cytokines - blood</topic><topic>Cytokines - drug effects</topic><topic>Dose-Response Relationship, Drug</topic><topic>Fatigue - chemically induced</topic><topic>Female</topic><topic>Fever - chemically induced</topic><topic>Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage</topic><topic>Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Injections, Subcutaneous</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - adverse effects</topic><topic>Interleukin-2 - administration & dosage</topic><topic>Interleukin-2 - adverse effects</topic><topic>Kidney Neoplasms - drug therapy</topic><topic>Kidney Neoplasms - immunology</topic><topic>Killer Cells, Natural - cytology</topic><topic>Killer Cells, Natural - drug effects</topic><topic>Killer Cells, Natural - immunology</topic><topic>Lymphocyte Count - drug effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Melanoma - drug therapy</topic><topic>Melanoma - immunology</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Pharmacology. Drug treatments</topic><topic>Receptors, Interleukin-2 - blood</topic><topic>Receptors, Interleukin-2 - drug effects</topic><topic>T-Lymphocytes - cytology</topic><topic>T-Lymphocytes - drug effects</topic><topic>T-Lymphocytes - immunology</topic><topic>Treatment Outcome</topic><topic>Weight Gain - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Gast, G C</creatorcontrib><creatorcontrib>Klümpen, H J</creatorcontrib><creatorcontrib>Vyth-Dreese, F A</creatorcontrib><creatorcontrib>Kersten, M J</creatorcontrib><creatorcontrib>Verra, N C</creatorcontrib><creatorcontrib>Sein, J</creatorcontrib><creatorcontrib>Batchelor, D</creatorcontrib><creatorcontrib>Nooijen, W J</creatorcontrib><creatorcontrib>Schornagel, J H</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Gast, G C</au><au>Klümpen, H J</au><au>Vyth-Dreese, F A</au><au>Kersten, M J</au><au>Verra, N C</au><au>Sein, J</au><au>Batchelor, D</au><au>Nooijen, W J</au><au>Schornagel, J H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I Trial of Combined Immunotherapy with Subcutaneous Granulocyte Macrophage Colony-stimulating Factor, Low-Dose Interleukin 2, and Interferon α in Progressive Metastatic Melanoma and Renal Cell Carcinoma</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2000-04-01</date><risdate>2000</risdate><volume>6</volume><issue>4</issue><spage>1267</spage><epage>1272</epage><pages>1267-1272</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>The purpose
of our study was to determine the maximally tolerated dose (MTD) and
DLT of combined administration of granulocyte macrophage
colony-stimulating factor (GM-CSF), low-dose interleukin 2 (IL-2) and
IFN-α in patients with progressive metastatic melanoma or renal cell
carcinoma (RCC). In addition, the activation and expansion of effector
cells were measured. Cohorts of three patients were treated with
increasing doses of IL-2 (1, 4, and 8 MIU/m 2 ) and GM-CSF
(2.5 and 5 μg/kg) with a constant dose of IFNα (5 million
units) s.c. for 12 days every 3 weeks. An additional six
patients were treated at the MTD. Immune activation was monitored
during the first cycle. Response was evaluated after two cycles. The
MTD was found to be 2.5 μg/kg GM-CSF, 4 MIU/m 2 IL-2, and
5 mega units of IFNα. DLT was grade 4 fever, chills with hypotension,
grade 3 fatigue/malaise, and fluid retention. Dose reduction of
IL-2 to 2 MIU/m 2 was necessary in three of nine patients
who initially received the MTD. Treatment was initiated in the hospital
but could be continued at home after 3–4 days. Significant increases
in lymphocytes, (activated) T cells (CD4+ and CD8+), NK cells,
monocyte DR expression, neutrophils, and eosinophils were found.
CD8+ T-cell activation (sCD8) and NK cell expansion was mainly
present in patients receiving 2 or 4 MIU/m 2 IL-2. Of eight
patients with progressive metastatic RCC after nephrectomy, three
achieved a complete remission, and 1 of 7 patients with metastatic
melanoma achieved a partial remission. In our study, the MTD of
combined immunotherapy with GM-CSF, IL-2, and IFNα was established;
DLT was: ( a ) grade 4 fever with hypotension needing i.v.
fluid support; and ( b ) grade 3 fluid retention and/or
fatigue/malaise. The scheme resulted in considerable expansion
and/or activation of various effector cells. The complete responses in
RCC patients are promising but need to be confirmed in Phase II
studies.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>10778950</pmid><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1078-0432 |
| ispartof | Clinical cancer research, 2000-04, Vol.6 (4), p.1267-1272 |
| issn | 1078-0432 1557-3265 |
| language | eng |
| recordid | cdi_pubmed_primary_10778950 |
| source | MEDLINE; American Association for Cancer Research; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - immunology CD8 Antigens - blood CD8 Antigens - drug effects Cytokines - blood Cytokines - drug effects Dose-Response Relationship, Drug Fatigue - chemically induced Female Fever - chemically induced Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects Humans Immunotherapy Injections, Subcutaneous Interferon-alpha - administration & dosage Interferon-alpha - adverse effects Interleukin-2 - administration & dosage Interleukin-2 - adverse effects Kidney Neoplasms - drug therapy Kidney Neoplasms - immunology Killer Cells, Natural - cytology Killer Cells, Natural - drug effects Killer Cells, Natural - immunology Lymphocyte Count - drug effects Male Medical sciences Melanoma - drug therapy Melanoma - immunology Middle Aged Neoplasm Metastasis Pharmacology. Drug treatments Receptors, Interleukin-2 - blood Receptors, Interleukin-2 - drug effects T-Lymphocytes - cytology T-Lymphocytes - drug effects T-Lymphocytes - immunology Treatment Outcome Weight Gain - drug effects |
| title | Phase I Trial of Combined Immunotherapy with Subcutaneous Granulocyte Macrophage Colony-stimulating Factor, Low-Dose Interleukin 2, and Interferon α in Progressive Metastatic Melanoma and Renal Cell Carcinoma |
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