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Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma
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| Zeitschriftentitel: | Clinical Cancer Research |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , , |
| In: | Clinical Cancer Research, 15, 2009, 20, S. 6446-6453 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Association for Cancer Research (AACR)
|
| Schlagwörter: |
| author_facet |
Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. |
|---|---|
| author |
Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. |
| spellingShingle |
Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. Clinical Cancer Research Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma Cancer Research Oncology |
| author_sort |
ansell, stephen m. |
| spelling |
Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. 1078-0432 1557-3265 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1078-0432.ccr-09-1339 <jats:title>Abstract</jats:title> <jats:p>Purpose: The growth of non–Hodgkin lymphomas can be influenced by tumor–immune system interactions. Cytotoxic T-lymphocyte antigen 4 (CTLA-4) is a negative regulator of T-cell activation that serves to dampen antitumor immune responses. Blocking anti–CTLA-4 monoclonal antibodies improves host resistance to immunogenic tumors, and the anti–CTLA-4 antibody ipilimumab (MDX-010) has clinical activity against melanoma, prostate, and ovarian cancers.</jats:p> <jats:p>Experimental Design: We did a phase I trial of ipilimumab in patients with relapsed/refractory B-cell lymphoma to evaluate safety, immunologic activity, and potential clinical efficacy. Treatment consisted of ipilimumab at 3 mg/kg and then monthly at 1 mg/kg × 3 months (dose level 1), with subsequent escalation to 3 mg/kg monthly × 4 months (dose level 2).</jats:p> <jats:p>Results: Eighteen patients were treated, 12 at the lower dose level and 6 at the higher dose level. Ipilimumab was generally well tolerated, with common adverse events attributed to it, including diarrhea, headache, abdominal pain, anorexia, fatigue, neutropenia, and thrombocytopenia. Two patients had clinical responses; one patient with diffuse large B-cell lymphoma had an ongoing complete response (&gt;31 months), and one with follicular lymphoma had a partial response lasting 19 months. In 5 of 16 cases tested (31%), T-cell proliferation to recall antigens was significantly increased (&gt;2-fold) after ipilimumab therapy.</jats:p> <jats:p>Conclusions: Blockade of CTLA-4 signaling with the use of ipilimumab is well tolerated at the doses used and has antitumor activity in patients with B-cell lymphoma. Further evaluation of ipilimumab alone or in combination with other agents in B-cell lymphoma patients is therefore warranted. (Clin Cancer Res 2009;15(20):6446–53)</jats:p> Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma Clinical Cancer Research |
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10.1158/1078-0432.ccr-09-1339 |
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American Association for Cancer Research (AACR), 2009 |
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American Association for Cancer Research (AACR), 2009 |
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1078-0432 1557-3265 |
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| title |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_unstemmed |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_full |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_fullStr |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_full_unstemmed |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_short |
Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_sort |
phase i study of ipilimumab, an anti–ctla-4 monoclonal antibody, in patients with relapsed and refractory b-cell non–hodgkin lymphoma |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1158/1078-0432.ccr-09-1339 |
| publishDate |
2009 |
| physical |
6446-6453 |
| description |
<jats:title>Abstract</jats:title>
<jats:p>Purpose: The growth of non–Hodgkin lymphomas can be influenced by tumor–immune system interactions. Cytotoxic T-lymphocyte antigen 4 (CTLA-4) is a negative regulator of T-cell activation that serves to dampen antitumor immune responses. Blocking anti–CTLA-4 monoclonal antibodies improves host resistance to immunogenic tumors, and the anti–CTLA-4 antibody ipilimumab (MDX-010) has clinical activity against melanoma, prostate, and ovarian cancers.</jats:p>
<jats:p>Experimental Design: We did a phase I trial of ipilimumab in patients with relapsed/refractory B-cell lymphoma to evaluate safety, immunologic activity, and potential clinical efficacy. Treatment consisted of ipilimumab at 3 mg/kg and then monthly at 1 mg/kg × 3 months (dose level 1), with subsequent escalation to 3 mg/kg monthly × 4 months (dose level 2).</jats:p>
<jats:p>Results: Eighteen patients were treated, 12 at the lower dose level and 6 at the higher dose level. Ipilimumab was generally well tolerated, with common adverse events attributed to it, including diarrhea, headache, abdominal pain, anorexia, fatigue, neutropenia, and thrombocytopenia. Two patients had clinical responses; one patient with diffuse large B-cell lymphoma had an ongoing complete response (&gt;31 months), and one with follicular lymphoma had a partial response lasting 19 months. In 5 of 16 cases tested (31%), T-cell proliferation to recall antigens was significantly increased (&gt;2-fold) after ipilimumab therapy.</jats:p>
<jats:p>Conclusions: Blockade of CTLA-4 signaling with the use of ipilimumab is well tolerated at the doses used and has antitumor activity in patients with B-cell lymphoma. Further evaluation of ipilimumab alone or in combination with other agents in B-cell lymphoma patients is therefore warranted. (Clin Cancer Res 2009;15(20):6446–53)</jats:p> |
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| author | Ansell, Stephen M., Hurvitz, Sara A., Koenig, Patricia A., LaPlant, Betsy R., Kabat, Brian F., Fernando, Donna, Habermann, Thomas M., Inwards, David J., Verma, Meena, Yamada, Reiko, Erlichman, Charles, Lowy, Israel, Timmerman, John M. |
| author_facet | Ansell, Stephen M., Hurvitz, Sara A., Koenig, Patricia A., LaPlant, Betsy R., Kabat, Brian F., Fernando, Donna, Habermann, Thomas M., Inwards, David J., Verma, Meena, Yamada, Reiko, Erlichman, Charles, Lowy, Israel, Timmerman, John M., Ansell, Stephen M., Hurvitz, Sara A., Koenig, Patricia A., LaPlant, Betsy R., Kabat, Brian F., Fernando, Donna, Habermann, Thomas M., Inwards, David J., Verma, Meena, Yamada, Reiko, Erlichman, Charles, Lowy, Israel, Timmerman, John M. |
| author_sort | ansell, stephen m. |
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| description | <jats:title>Abstract</jats:title> <jats:p>Purpose: The growth of non–Hodgkin lymphomas can be influenced by tumor–immune system interactions. Cytotoxic T-lymphocyte antigen 4 (CTLA-4) is a negative regulator of T-cell activation that serves to dampen antitumor immune responses. Blocking anti–CTLA-4 monoclonal antibodies improves host resistance to immunogenic tumors, and the anti–CTLA-4 antibody ipilimumab (MDX-010) has clinical activity against melanoma, prostate, and ovarian cancers.</jats:p> <jats:p>Experimental Design: We did a phase I trial of ipilimumab in patients with relapsed/refractory B-cell lymphoma to evaluate safety, immunologic activity, and potential clinical efficacy. Treatment consisted of ipilimumab at 3 mg/kg and then monthly at 1 mg/kg × 3 months (dose level 1), with subsequent escalation to 3 mg/kg monthly × 4 months (dose level 2).</jats:p> <jats:p>Results: Eighteen patients were treated, 12 at the lower dose level and 6 at the higher dose level. Ipilimumab was generally well tolerated, with common adverse events attributed to it, including diarrhea, headache, abdominal pain, anorexia, fatigue, neutropenia, and thrombocytopenia. Two patients had clinical responses; one patient with diffuse large B-cell lymphoma had an ongoing complete response (&gt;31 months), and one with follicular lymphoma had a partial response lasting 19 months. In 5 of 16 cases tested (31%), T-cell proliferation to recall antigens was significantly increased (&gt;2-fold) after ipilimumab therapy.</jats:p> <jats:p>Conclusions: Blockade of CTLA-4 signaling with the use of ipilimumab is well tolerated at the doses used and has antitumor activity in patients with B-cell lymphoma. Further evaluation of ipilimumab alone or in combination with other agents in B-cell lymphoma patients is therefore warranted. (Clin Cancer Res 2009;15(20):6446–53)</jats:p> |
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| spelling | Ansell, Stephen M. Hurvitz, Sara A. Koenig, Patricia A. LaPlant, Betsy R. Kabat, Brian F. Fernando, Donna Habermann, Thomas M. Inwards, David J. Verma, Meena Yamada, Reiko Erlichman, Charles Lowy, Israel Timmerman, John M. 1078-0432 1557-3265 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1078-0432.ccr-09-1339 <jats:title>Abstract</jats:title> <jats:p>Purpose: The growth of non–Hodgkin lymphomas can be influenced by tumor–immune system interactions. Cytotoxic T-lymphocyte antigen 4 (CTLA-4) is a negative regulator of T-cell activation that serves to dampen antitumor immune responses. Blocking anti–CTLA-4 monoclonal antibodies improves host resistance to immunogenic tumors, and the anti–CTLA-4 antibody ipilimumab (MDX-010) has clinical activity against melanoma, prostate, and ovarian cancers.</jats:p> <jats:p>Experimental Design: We did a phase I trial of ipilimumab in patients with relapsed/refractory B-cell lymphoma to evaluate safety, immunologic activity, and potential clinical efficacy. Treatment consisted of ipilimumab at 3 mg/kg and then monthly at 1 mg/kg × 3 months (dose level 1), with subsequent escalation to 3 mg/kg monthly × 4 months (dose level 2).</jats:p> <jats:p>Results: Eighteen patients were treated, 12 at the lower dose level and 6 at the higher dose level. Ipilimumab was generally well tolerated, with common adverse events attributed to it, including diarrhea, headache, abdominal pain, anorexia, fatigue, neutropenia, and thrombocytopenia. Two patients had clinical responses; one patient with diffuse large B-cell lymphoma had an ongoing complete response (&gt;31 months), and one with follicular lymphoma had a partial response lasting 19 months. In 5 of 16 cases tested (31%), T-cell proliferation to recall antigens was significantly increased (&gt;2-fold) after ipilimumab therapy.</jats:p> <jats:p>Conclusions: Blockade of CTLA-4 signaling with the use of ipilimumab is well tolerated at the doses used and has antitumor activity in patients with B-cell lymphoma. Further evaluation of ipilimumab alone or in combination with other agents in B-cell lymphoma patients is therefore warranted. (Clin Cancer Res 2009;15(20):6446–53)</jats:p> Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma Clinical Cancer Research |
| spellingShingle | Ansell, Stephen M., Hurvitz, Sara A., Koenig, Patricia A., LaPlant, Betsy R., Kabat, Brian F., Fernando, Donna, Habermann, Thomas M., Inwards, David J., Verma, Meena, Yamada, Reiko, Erlichman, Charles, Lowy, Israel, Timmerman, John M., Clinical Cancer Research, Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma, Cancer Research, Oncology |
| title | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_full | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_fullStr | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_full_unstemmed | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_short | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| title_sort | phase i study of ipilimumab, an anti–ctla-4 monoclonal antibody, in patients with relapsed and refractory b-cell non–hodgkin lymphoma |
| title_unstemmed | Phase I Study of Ipilimumab, an Anti–CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell Non–Hodgkin Lymphoma |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1158/1078-0432.ccr-09-1339 |