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Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma
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| Zeitschriftentitel: | The Journal of Clinical Endocrinology & Metabolism |
|---|---|
| Personen und Körperschaften: | , , , , , , , |
| In: | The Journal of Clinical Endocrinology & Metabolism, 103, 2018, 1, S. 213-220 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
The Endocrine Society
|
| Schlagwörter: |
| author_facet |
Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J |
|---|---|
| author |
Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J |
| spellingShingle |
Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J The Journal of Clinical Endocrinology & Metabolism Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma Biochemistry (medical) Clinical Biochemistry Endocrinology Biochemistry Endocrinology, Diabetes and Metabolism |
| author_sort |
noto, richard b |
| spelling |
Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J 0021-972X 1945-7197 The Endocrine Society Biochemistry (medical) Clinical Biochemistry Endocrinology Biochemistry Endocrinology, Diabetes and Metabolism http://dx.doi.org/10.1210/jc.2017-02030 <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Context</jats:title> <jats:p>No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>Three centers.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients</jats:title> <jats:p>Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention</jats:title> <jats:p>Open-label use of high-specific-activity I-131 MIBG therapy.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>Dose-limiting toxicities, adverse events, radiation absorbed dose estimates, radiographic tumor response, biochemical response, and survival.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The MTD was determined to be 296 MBq/kg on the basis of two observed dose-limiting toxicities at the next dose level. The highest mean radiation absorbed dose estimates were in the thyroid and lower large intestinal wall (each 1.2 mGy/MBq). Response was evaluated by total administered activity: four patients (19%), all of whom received &gt;18.5 GBq of study drug, had radiographic tumor responses of partial response by Response Evaluation Criteria in Solid Tumors. Best biochemical responses (complete or partial response) for serum chromogranin A and total metanephrines were observed in 80% and 64% of patients, respectively. Overall survival was 85.7% at 1 year and 61.9% at 2 years after treatment. The majority (84%) of adverse events were considered mild or moderate in severity.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>These findings support further development of high-specific-activity I-131 MIBG for the treatment of metastatic and/or recurrent PPGL at an MTD of 296 MBq/kg.</jats:p> </jats:sec> Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma The Journal of Clinical Endocrinology & Metabolism |
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10.1210/jc.2017-02030 |
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The Endocrine Society, 2018 |
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The Endocrine Society, 2018 |
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| title |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_unstemmed |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_full |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_fullStr |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_full_unstemmed |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_short |
Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_sort |
phase 1 study of high-specific-activity i-131 mibg for metastatic and/or recurrent pheochromocytoma or paraganglioma |
| topic |
Biochemistry (medical) Clinical Biochemistry Endocrinology Biochemistry Endocrinology, Diabetes and Metabolism |
| url |
http://dx.doi.org/10.1210/jc.2017-02030 |
| publishDate |
2018 |
| physical |
213-220 |
| description |
<jats:title>Abstract</jats:title>
<jats:sec>
<jats:title>Context</jats:title>
<jats:p>No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Objective</jats:title>
<jats:p>To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Design</jats:title>
<jats:p>Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Setting</jats:title>
<jats:p>Three centers.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Patients</jats:title>
<jats:p>Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Intervention</jats:title>
<jats:p>Open-label use of high-specific-activity I-131 MIBG therapy.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Main Outcome Measures</jats:title>
<jats:p>Dose-limiting toxicities, adverse events, radiation absorbed dose estimates, radiographic tumor response, biochemical response, and survival.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Results</jats:title>
<jats:p>The MTD was determined to be 296 MBq/kg on the basis of two observed dose-limiting toxicities at the next dose level. The highest mean radiation absorbed dose estimates were in the thyroid and lower large intestinal wall (each 1.2 mGy/MBq). Response was evaluated by total administered activity: four patients (19%), all of whom received &gt;18.5 GBq of study drug, had radiographic tumor responses of partial response by Response Evaluation Criteria in Solid Tumors. Best biochemical responses (complete or partial response) for serum chromogranin A and total metanephrines were observed in 80% and 64% of patients, respectively. Overall survival was 85.7% at 1 year and 61.9% at 2 years after treatment. The majority (84%) of adverse events were considered mild or moderate in severity.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>These findings support further development of high-specific-activity I-131 MIBG for the treatment of metastatic and/or recurrent PPGL at an MTD of 296 MBq/kg.</jats:p>
</jats:sec> |
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| author | Noto, Richard B, Pryma, Daniel A, Jensen, Jessica, Lin, Tess, Stambler, Nancy, Strack, Thomas, Wong, Vivien, Goldsmith, Stanley J |
| author_facet | Noto, Richard B, Pryma, Daniel A, Jensen, Jessica, Lin, Tess, Stambler, Nancy, Strack, Thomas, Wong, Vivien, Goldsmith, Stanley J, Noto, Richard B, Pryma, Daniel A, Jensen, Jessica, Lin, Tess, Stambler, Nancy, Strack, Thomas, Wong, Vivien, Goldsmith, Stanley J |
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| description | <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Context</jats:title> <jats:p>No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>Three centers.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients</jats:title> <jats:p>Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention</jats:title> <jats:p>Open-label use of high-specific-activity I-131 MIBG therapy.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>Dose-limiting toxicities, adverse events, radiation absorbed dose estimates, radiographic tumor response, biochemical response, and survival.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The MTD was determined to be 296 MBq/kg on the basis of two observed dose-limiting toxicities at the next dose level. The highest mean radiation absorbed dose estimates were in the thyroid and lower large intestinal wall (each 1.2 mGy/MBq). Response was evaluated by total administered activity: four patients (19%), all of whom received &gt;18.5 GBq of study drug, had radiographic tumor responses of partial response by Response Evaluation Criteria in Solid Tumors. Best biochemical responses (complete or partial response) for serum chromogranin A and total metanephrines were observed in 80% and 64% of patients, respectively. Overall survival was 85.7% at 1 year and 61.9% at 2 years after treatment. The majority (84%) of adverse events were considered mild or moderate in severity.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>These findings support further development of high-specific-activity I-131 MIBG for the treatment of metastatic and/or recurrent PPGL at an MTD of 296 MBq/kg.</jats:p> </jats:sec> |
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| spelling | Noto, Richard B Pryma, Daniel A Jensen, Jessica Lin, Tess Stambler, Nancy Strack, Thomas Wong, Vivien Goldsmith, Stanley J 0021-972X 1945-7197 The Endocrine Society Biochemistry (medical) Clinical Biochemistry Endocrinology Biochemistry Endocrinology, Diabetes and Metabolism http://dx.doi.org/10.1210/jc.2017-02030 <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Context</jats:title> <jats:p>No therapies are approved for the treatment of metastatic and/or recurrent pheochromocytoma or paraganglioma (PPGL) in the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To determine the maximum tolerated dose (MTD) of high-specific-activity I-131 meta-iodobenzylguanidine (MIBG) for the treatment of metastatic and/or recurrent PPGL.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Phase 1, dose-escalating study to determine the MTD via a standard 3 + 3 design, escalating by 37 MBq/kg starting at 222 MBq/kg.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>Three centers.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients</jats:title> <jats:p>Twenty-one patients were eligible, received study drug, and were evaluable for MTD, response, and toxicity.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention</jats:title> <jats:p>Open-label use of high-specific-activity I-131 MIBG therapy.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>Dose-limiting toxicities, adverse events, radiation absorbed dose estimates, radiographic tumor response, biochemical response, and survival.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The MTD was determined to be 296 MBq/kg on the basis of two observed dose-limiting toxicities at the next dose level. The highest mean radiation absorbed dose estimates were in the thyroid and lower large intestinal wall (each 1.2 mGy/MBq). Response was evaluated by total administered activity: four patients (19%), all of whom received &gt;18.5 GBq of study drug, had radiographic tumor responses of partial response by Response Evaluation Criteria in Solid Tumors. Best biochemical responses (complete or partial response) for serum chromogranin A and total metanephrines were observed in 80% and 64% of patients, respectively. Overall survival was 85.7% at 1 year and 61.9% at 2 years after treatment. The majority (84%) of adverse events were considered mild or moderate in severity.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>These findings support further development of high-specific-activity I-131 MIBG for the treatment of metastatic and/or recurrent PPGL at an MTD of 296 MBq/kg.</jats:p> </jats:sec> Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma The Journal of Clinical Endocrinology & Metabolism |
| spellingShingle | Noto, Richard B, Pryma, Daniel A, Jensen, Jessica, Lin, Tess, Stambler, Nancy, Strack, Thomas, Wong, Vivien, Goldsmith, Stanley J, The Journal of Clinical Endocrinology & Metabolism, Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma, Biochemistry (medical), Clinical Biochemistry, Endocrinology, Biochemistry, Endocrinology, Diabetes and Metabolism |
| title | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_full | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_fullStr | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_full_unstemmed | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_short | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| title_sort | phase 1 study of high-specific-activity i-131 mibg for metastatic and/or recurrent pheochromocytoma or paraganglioma |
| title_unstemmed | Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma |
| topic | Biochemistry (medical), Clinical Biochemistry, Endocrinology, Biochemistry, Endocrinology, Diabetes and Metabolism |
| url | http://dx.doi.org/10.1210/jc.2017-02030 |