Table 3.
Characteristics of ongoing pharmacotherapy clinical trials.
| Investigator | NCT Number | Region | Funding | Intervention | Trial Sites | Phase | Target Enrollment | Meningioma Only | Study Length | Recruitment status | Primary Outcome of Interest |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemotherapy | |||||||||||
| Scott R. Plotkin | 03071874 | USA | Both | AZD2014 (vistusertib), PO BID on days 2 and 7; 28-day cycles | 3 | 2 | 25 | Yes | 2017–2024 | Active, not recruiting | PFS |
| Thomas Graillon | 03631953 | France | Public | Trametinib (1.5 mg/d daily), Alpelisib (120–200 mg/d daily) | 1 | 1 | 25 | Yes | 2019–2022 | Recruiting | Toxicity |
| Jun-ping Zhang | 04501705 | China | Private | Apatinib Mesylate, 500 mg PO daily, until progressive disease; 28-day cycles | 1 | N/A | 29 | Yes | 2020–2025 | Recruiting | PFS |
| Nader Sanai | 02933736 | USA | Private | Ribociclib (LEE011), 900 mg PO QD; total of 5 doses before surgery | 1 | 1 | 48 | No | 2016–2022 | Recruiting | Pharmacokinetics, Toxicity |
| Rupesh Kotecha | 05425004 | USA | Private | Cabozantinib 60 mg QD for 28 days | 1 | 2 | 24 | Yes | 2022–2024 | Recruiting | PFS |
| NA | 05130866 | NA | Private | AR-42 (OSU-HDAC42) 30–60 mg 3 times a wk followed by 1 wk off | NA | 2/3 | 89 | Yes | 2021–2027 | Not yet recruiting | PFS |
| Ludimila Cavalcante | 04239092 | USA | Private | 9-ING-41 (9.3 mg/kg IV twice per week), w. or w/o irinotecan (50 mg/m2/d IV days 1–5 of 21 d cycles) | 8 | 1 | 48 | No | 2020–2023 | Recruiting | Toxicity |
| Scott Plotkin | 04374305 | USA | Private | Brigatinib, PO daily | 4 | 2 | 80 | No | 2020–2029 | Recruiting | PFS |
| Trent Hummel | 03095248 | USA | Private | Selumetinib, 75 mg/d PO BID; 28 d cycles. up to 2 y | 1 | 2 | 34 | No | 2017–2023 | Recruiting | PFS |
| Mark Gilbert | 04541082 | USA | Both | ONC206 (imipridone class of anti-cancer small molecules) | 1 | 1 | 102 | No | 2020–2024 | Recruiting | Toxicity |
| Giles W. Robinson | 03434262 | USA | Private | Gemcitabine (IV), ribociclib (PO), sonidegib (PO), trametinib (PO), G-CSF (SC) | 1 | 1 | 108 | No | 2018–2025 | Recruiting | Pharmacokinetics, Toxicity |
| Priscilla Brastianos | 02523014 | USA | Both | A: Vismodegib PO Q.D.; 28 d cycles B: GSK2256098 PO QD; 28 d cycles C: Capivasertib PO BID; days 1–4 of 7 D: Abemaciclib PO BID; 28 d cycles |
705 | 2 | 124 | Yes | 2015–2024 | Recruiting | PFS |
| Thomas Kaley | 03220646 | USA | Private | Abemaciclib, 200 mg PO BID; 28 d cycles | 8 | 2 | 78 | No | 2017–2023 | Recruiting | PFS, RRR |
| Santosh Kesari | 02423525 | USA | Private | Afatinib, 80–280 mg, PO every 4 d or 7 d | 1 | 1 | 24 | No | 2016–2021 | Active, not recruiting | Toxicity |
| Hormone Therapy | |||||||||||
| Dominik Cordier | 04997317 | Switzerland | Public | A: IV 4.5 GBq 177Lu-DOTA-JR11 (300–1300 ug) once; 2nd cycle of 200 ug B: IV 4.5 GBq 177Lu-DOTA-JR11 (300–1300 ug) once; 2nd cycle of 200 ug |
1 | 1 | 18 | Yes | 2021–2025 | Recruiting | Toxicity |
| Kenneth Merrell | 04082520 | USA | Public | IV Ga 68-DOTATE and then IV 177Lu-DOTA over 30–40 min. Cycles repeat every 8 wk for up to 6 mo. | 1 | 2 | 41 | Yes | 2019–2024 | Recruiting | PFS |
| Ralph Salloum | 05278208 | USA | Public | IV 177Lu-DOTATE (200 mCi) once every 8 wk for 8 mo. | 9 | 1/2 | 65 | No | 2022–2026 | Not yet recruiting | Toxicity PFS |
| Erik Sulman | 03971461 | USA | Private | IV 177Lu-DOTATE every 8 wk for 4 doses | 2 | 2 | 32 | Yes | 2019–2023 | Recruiting | PFS |
| Biological Therapy | |||||||||||
| David Reardon | 02648997 | USA | Private | A. nivolumab, 240 mg q2w. B. EBRT followed by 4 cycles of nivolumab (2mg/kg q3w) + ipilimumab (1 mg/kg every 3 weeks) followed by nivolumab (480 mg q4w) |
1 | 2 | 50 | Yes | 2016–2023 | Recruiting | PFS |
| Priscilla Brastianos | 03279692 | USA | Private | IV pembrolizumab q3w | 2 | 2 | 26 | Yes | 2017–2021 | Active, not recruiting | PFS |
| Feng Chen | 04728568 | China | Public | IV sintilimab q3w | 1 | NA | 15 | Yes | 2020–2023 | Recruiting | PFS |
| Jiayi Huang | 03267836 | USA | Private | IV avelumab (10 mg/kg) and proton therapy (30 CGE) q2w for 3 mo. Surgical evaluation at 3 mo. | 1 | 1 | 9 | Yes | 2017–2023 | Active, not recruiting | Immunogenicity Tumor size |
| Jiayi Huang | 03604978 | USA | Public | A. IV nivolumab; 28 d cycles for 1 y. Multi-fraction stereotactic radiosurgery (days 1,3, and 5) B. IV nivolumab q2w for 6 mo. followed by q4w for 6 mo. IV ipilimumab q6w for 6 mo. multi-fraction stereotactic radiosurgery (days 1,3, and 5) |
22 | 1/2 | 15 | Yes | 2018–2022 | Active, not recruiting | Toxicity RRR |
| Nancy Bush | 04659811 | USA | Private | IV pembrolizumab 200 mg q3w with SRS | 1 | 2 | 90 | Yes | 2020–2024 | Recruiting | PFS |
| Marta Penas-Prado | 03173950 | USA | Public | IV nivolumab 240 mg q2w for 2 cycles and then 480 mg q4w for a total 14 doses | 7 | 2 | 180 | No | 2017–2023 | Recruiting | PFS |
| NA | 05023018 | NA | Private | NEO100 self-administered qid on 28 d cycle for up to 12 cycles | NA | 2 | 30 | Yes | 2021–2026 | Not yet recruiting | Toxicity PFS |
| Priya Kumthekar | 02847559 | USA | Both | IV bevacizumab q2w for 4 cycles and then q2w or q3w + daily electric field therapy with Optune device | 9 | 2 | 27 | Yes | 2016–2024 | Recruiting | PFS |
PO., per os; d, day(s); wk, week(s); IV, intravenous; w., with; w/o, without; y, year(s); SC, subcutaneous; PFS, Progression Free Survival; RRR, Radiological Response Rate.