TABLE 1.
summary of CED clinical trials involving patients with glioblastoma*
| Authors & Year |
Agent Convected (type) |
Trial Phase |
Site of Study |
Drug Classification | WHO Grade, Tumor Type (no. of pts) |
Flow Rate | Vol Infused |
Duration | Tracking | No. of Catheters |
|---|---|---|---|---|---|---|---|---|---|---|
| Laske et al., 1997 | TF-CRM107 (synthetic protein exotoxin) | I | NIH/Temple | Synthetic protein endotoxin | Recurrent Gr IV GBM (10), Gr III AA (5), AO (1), metastatic lung CA (1) | Incrementally increasing w/each Tx, up to 16 mg/day | 5–180 ml | Up to 16 days | 1–3 | |
| Weaver et al., 2003 | TF-CRM107 (synthetic protein exotoxin) | II | Temple | Synthetic protein endotoxin | Recurrent Gr IV GBM & Gr III AA (44)† | 0.2 ml/hr | 2 | |||
| Rand et al., 2000 | NBI-3001 (IL4-Pseu-domonas exotoxin) | I | NIH | Chimeric recomb fusion protein | Recurrent or progr Gr IV GBM (9) | 0.3–0.6 ml/hr | 30–185 ml | 4–8 days | 1 | |
| Weber et al., 2003 | NBI-3001 (IL4-Pseu-domonas exotoxin) | I | Chimeric recomb fusion protein | Recurrent Gr IV GBM (25), Gr III AA (31) | 40–100 ml | 1–45 days | 1 | |||
| Lidar et al., 2004 | Paclitaxel | I/II | Israel | Taxane chemo | Recurrent Gr IV GBM (13), Gr III AA (2) | 0.3 ml/hr | 5 days | 1 | ||
| Patel et al., 2005 | Cotara | I/II | 4 diff’t institutions | 131I-labeled chimeric MAb (131I-chTNT-1/B MAb) specific for a universal intracellular antigen (i.e., histone H1 complexed to DNA) | Recurrent Gr IV GBM (37), newly diagnosed Gr IV GBM (8), Gr III AA (6) | 0.18 ml/hr | 4.5 ml | 1–2 days | SPECT | 1 |
| Vogelbaum et al., 2007 | IL-13 PE38QQR (Cintredekin besudotox) | I | Chimeric recomb fusion protein | Newly diagnosed Gr IV GBM (21), Gr III AO (1) | 0.75 ml/hr | 96 hrs | 1 | |||
| Kunwar et al., 2007 | IL-13 PE38QQR (Cintredekin besudotox) | I | Chimeric recomb fusion protein | Recurrent or progr Gr IV GBM (46), Gr III AA or AO (5) | 0.75 ml/hr | 96 hrs | Radiolabeled HAS | 1 | ||
| Kunwar et al., 2010 | IL-13 PE38QQR (Cintredekin besudotox) vs Gliadel wafers | III | 52 diff’t sites | Chimeric recomb fusion protein | Newly diagnosed Gr IV GBM (296) | 0.75 ml/hr | 96 hs | 2–4 | ||
| Sampson et al., 2008 | TP-38 | I | Chimeric recomb fusion protein | Recurrent or progr Gr IV GBM (20) | 0.4 ml/hr | 20 ml | 50 hrs | Radiolabeled albumin | Mult | |
| Bogdahn et al., 2011 | Trabedersen | II | Synthetic antisense phosphorothioate oligodeoxynucleotide | Recurrent or progr Gr IV GBM (103), Gr III AA (42) | 4 μl/min | 7 days | 1 | |||
| Bruce et al., 2011 | Topotecan | I | Columbia | Cytotoxicquinoline alkaloid–derived chemo | Recurrent Gr IV GBM (10), Gr III glioma (6) | 200 μl/hr | 40 ml | 100 hrs | Gadopentetate, gadodiamide, or gadobenate | 2 |
| Voges et al., 2003 | HSV-tk | I/II | 4 diff’t institutions | Gene-bearing liposomal vector | Recurrent Gr IV GBM (8) | 0.025–0.6 ml/hr | 3.5 ml | 29 days | 1 |
AA = anaplastic astrocytoma; AO = anaplastic oligodendroglioma; chemo = chemotherapeutic agent; diff’t = different; GBM = glioblastoma; Gr = grade; HSA = highly purified human serum albumin; lung CA = adenocarcinoma of lung; MAb = monoclonal antibody; mult = multiple; progr = progressive; pts = patients; recomb = recombinant; SPECT = single-photon emission computed tomography; Tx = treatment.
*
Shown are published results of 13 clinical trials using CED in glioblastoma patients.
†
Total of 44 patients; number per tumor type not specified.