Table 3.
Summary of ongoing clinical trials that obtain tumor tissue for analysis as part of their protocols
| Study | Phase Number | Number of Patients | Recruitment Status | Pathology | Drug | Dose | Schedule Prior to Surgery | Specimens | Physiologic Effect |
|---|---|---|---|---|---|---|---|---|---|
| NCT01849146 | Phase I | 36 | Recruiting | Recurrent glioblastoma | Adavosertib | Not specified | Not specified | Tumor, blood | pRb expression, Ki67, pCDC2, cleaved caspase 3 |
| NCT01986348 | Phase II | 110 | Active, not recruiting | Recurrent gliomas | Selinexor | 60 mg twice per week | 3 doses prior to surgery | Tumor, blood | |
| NCT02101905 | Pilot | 33 | Active, not recruiting | Recurrent high- grade glioma, EGFR amplified | Lapatinib | MTD | Days −2, and 0, last dose 3 h prior to surgery | Tumor | Total and phospho- EGFR, Ki67 |
| NCT02133183 | Phase I | 40 | Active, not recruiting | Recurrent glioblastoma | Sapanisertib | MTD | Not specified | Enhancing and non- enhancing tumor | IHC for pS6, p4EBP, pmTOR, and AKTpSer473; pharmacokinetics in enhancing tumor |
| NCT02337686 | Phase II | 18 | Active, not recruiting | Recurrent glioblastoma | Pembrolizumab | 200 mg i.v. | 2 doses q3weeks | Tumor, blood | Polyfunctional effector T cells:Treg ratio |
| NCT02525692 | Phase II | 76 | Recruiting | Recurrent glioblastoma ± H3 K27M mutation | ONC201 | Not specified | Not specified | Tumor | Not specified |
| NCT02630030 | Phase 0 | 3 | Completed | Recurrent or progressive glioblastoma | Ixazomib | Not specified | Oral dose 3 h prior to surgery | Tumor | Pharmacokinetics in tumor tissue |
| NCT02850744 | Phase II | 10 | Terminated | Recurrent glioblastoma | PQR309 | 80 mg | For 3 consecutive days prior to surgery | Tumor, CSF, skin | Pharmacokinetics in cerebrospinal fluid |
| NCT02852655 | Pilot | 35 | Active, not recruiting | Glioblastoma | Pembrolizumab | Tumor, blood | Tumor infiltrating T-lymphocyte density | ||
| NCT02933736 | Early phase I | 48 | Unknown | Meningioma | Ribociclib | 900 mg/d | 5 doses then 3 cohorts: 2–4, 4–8, 22–26 h after admin | Enhancing and non- enhancing tumor, CSF | Glioblastoma cohort published35 |
| NCT02981940 | Phase II | 36 | Active, not recruiting | Recurrent glioblastoma | Abemaciclib | b.i.d. | Short preoperative course | Enhancing tumor | pRB expression level |
| NCT03122197 | Phase 0/I | 42 | Recruiting | Recurrent gliomas | Letrozole | 2–12 mg/d | 1–5 days preop and continuing postop | Enhancing tumor | Area under the curve in tumor tissue |
| NCT03027388 | Phase II | 20 | Recruiting | Recurrent gliomas | LBIOO | 2.33 mg/m2 | 1–12 h prior to surgery | Tumor tissues | Pharmacokinetics parameters in tumor tissues |
| NCT03107780 | Phase 0/I | 86 | Recruiting | Recurrent glioblastoma | AMG-232 | Dose escalation | 2 doses prior to surgery (q.d. dosing) | Enhancing and nonenhancing tumor | Pharmacokinetics parameters in tumor tissue |