Year | Name of First Author | Country | Trial design | Schedule | Response criteria | Patients Enrolled | Tumor response | |||
---|---|---|---|---|---|---|---|---|---|---|
CR/PR | SD | PD | MR | |||||||
1991 | Hutchinson [28] | NSa | Single-arm Phase I | Doses ranged from 50-220 mCi, with cumulative doses of 50-654 mCi in one to three doses | Â | 14 | 4 | - | - | 2 |
1991 | Klingebiel [29] | Germany | NS | NS | NS | 47 | 9 | - | - | - |
1991 | Matthay [30] | NS | Single-arm Phase I | 100-400 mCi/m2/course | Â | 11 | 2 | 2 | 7 | 0 |
1991 | Troncone [31] | Italy | Single-arm Phase I | single doses (2.6-9.5 GBq) | Â | 11a | 2 | 4 | 2 | 1 |
1992 | Lashford [24] | UK | Single-arm Phase I | NS | ENSG Criteri a[24] | 25 | 8 | 9 | 7 | - |
1994 | Hoefnagel [14] | Netherlands | Single-arm Phase II | First 200mCi, If necessary, more cycles with100mCi at 4 weeks intervals | NS | 31 | 22 | 8 | - | - |
1995 | de Kraker [15] | Netherlands | Single-arm Phase II | First 200mCi, If necessary, more cycles with100mCi at 4-6 weeks intervals | INR C[32] | 33 | 19 | 11 | 3 | - |
1999 | Garaventa [17] | Italy | Single-arm Phase II | 67.5-148mCi 1-5 courses | INRC | 43 | 13 | - | 5 | 25 |
2005 | Howard [18] | USA | Single-arm Phase II | 3-19mCi/kg 2 to 4 courses | INRC | 28 | 11 | 8 | 8 | 1 |
2007 | Matthay [19] | USA | Single-arm Phase II | 12 or 18mCi/kg | INRC | 164 | 59 | 55 | 44 | 5 |
2008 | de Kraker [23] | Netherlands | Single-arm Phase II | 200 mCi for the first infusion and 100–150 mCi for the second and all subsequent infusions. | INRC | 41b | 27 | 5 | 4 | 4 |
2009 | Matthay [20] | USA | Single-arm Phase I | Day 0 and day 14, 12-21mCi/kg | RECIS T[33] | 20 | 10 | 3 | 7 | 8 |
2011 | Johnson [21] | USA | Single-arm Phase II | 18mCi/kg If necessary, additional 18mCi/kg were received within 100 days. | INRC | 117 | 35 | 52 | 30 | - |
2011 | Mastrangelo [34] | Italy | Pilot study | 131I-MIBG combined with other therapies | INRC | 13 | 6 | - | - | 1 |
2011 | Polishchuk [22] | USA | Single-arm Phase II | 17.8 millicuries (mCi)/kg | INRC | 39 | 18 | 17 | 2 | 2 |
2012 | DuBois [35] | USA | Single-arm Phase I | 131I-MIBG combined with other therapies | NANT Response Criteri a[35] | 24 | 6 | - | - | - |
2013 | Kushner [36] | USA | NS | 131I-MIBG combined with other therapies | INRC | 3 | 1 | 2 | 0 | 0 |
2015 | DuBois [37] | USA | Single-arm Phase I, II | 131I-MIBG combined with other therapies | NANT Response Criteria | 32 | 9 | - | - | - |
2015 | DuBois [38] | USA | Single-arm Phase I | 131I-MIBG combined with other therapies | NANT Response Criteria | 27 | 7 | - | - | - |
2015 | Kraal [39] | Netherlands | Single-arm Phase II | 131I-MIBG combined with other therapies | INRC | 16 | 9 | - | - | - |
2015 | Yanik [40] | USA | Single-arm Phase II | 131I-MIBG combined with other therapies | INRC | 49 | 7 | 26 | 6 | 10 |
2016 | George [41] | UK | NS | 131I-MIBG monotherapy | INRC | 25 | 15 | 8 | - | - |
2016 | Modak [42] | USA | Single-arm Phase II | 131I-MIBG combined with other therapies | INRC | 19 | 0 | - | 7 | - |
2019 | Genoll a[43] | Spain | NS | 131I-MIBG combined with other therapies | INRC, RECIST | 10 | 7 | 2 | 1 | 0 |
2020 | Anongpornjossakul [44] | Thailand | NS | mean dose of 136 mCi per treatment | RECIST 1.1 [45] | 22 | 7 | 3 | 12 | 0 |
2020 | Kayano [46] | Japan | NS | single dose of 444 to 666 MBq/kg | RECIST 1.1 | 19b | 5 | 10 | 3 | 0 |