Table 3. . Summary of recently completed Phase II clinical trials utilizing targeted agents or immunotherapy for newly diagnosed glioblastoma.
| Study (year) | Agent added to standard RT/TMZ | Patients (n) | Results | Ref. |
|---|---|---|---|---|
| Brown et al. (2008) | Erlotinib (150 mg q.d.) alone x 1 week, then concurrently with TMZ/RT and adjuvant TMZ | 97 | mPFS 7.2 months mOS 15.3 months |
[102] |
| Prados et al. (2009) | Erlotinib (100–200 mg q.d. during RT and 150–300 mg q.d. after RT) | 65 | mPFS 8.2 months mOS 19.3 months |
[104] |
| Grossman et al. (2009) | Talampanel (25–75 mg t.i.d.) | 72 | mOS 18.3 months (95% CI: 14.6–22.5 months) 2-year survival rate 41.7% |
[118] |
| Peereboom et al. (2010) | Erlotinib 50 mg/day, increased by 50 mg every 2 weeks until occurrence of grade 2 rash or maximum of 150 mg/day | 27 | mPFS 2.8 months mOS 8.6 months |
[103] |
| Stupp et al. (2010) | Cilengitide (500 mg twice weekly) | 52 | mPFS 8 months (95% CI: 6.0–10.7 months) mOS 16.1 months (95% CI: 13.1–23.2 months) 2-year survival rate: 35% |
[119] |
| Rosenfield et al.(2010) | im. poly-ICLC (20 mg/kg/dose given three-times per week for weeks 2–8) | 97 | mOS 17.2 months (95% CI: 15.4–19.3 months) 2-year survival rate: 23% |
[120] |
| Hainsworth et al. (2010) | Sorafenib 400 mg twice daily during adjuvant TMZ | 47 | mPFS 6 months (95% CI: 3.7–7 months) mOS 12 months (95% CI: 7.2–16 months) |
[121] |
| Uhm et al. (2011) | Gefitinib 500–1000 mg q.d. | 98 | mOS 12 months | [105] |
| Butowski et al. (2011) | Enzastaurin (250 mg q.d.) | 66 | mPFS 36 wk (95% CI: 30–49 weeks) mOS 74 wk (95% CI: 62–83 weeks) |
[113] |
| Lai et al. (2010) | Bevacizumab 10 mg/kg q2 week | 70 | mPFS 13.6 months mOS 19.6 months |
[11] |
| Vredenburgh et al. (2011) | Bevacizumab 10 mg/kg q2 week during standard RT/TMZ and bevacizumab 10 mg/kg q2 week plus irinotecan 125 mg/m2 q2 week during adjuvant TMZ | 75 | mPFS 14.2 months (95% CI: 12–16 months) mOS 21.2 months (95% CI: 17.2–25.4 months) |
[122] |
| Lai et al. (2011) | Rindopepimut (vaccine consisting of the EGFRvIII antigen chemically conjugated to Keyhole Limpet Hemocyanin) 500 µg id. q2 week first month, then monthly during adjuvant RT | 65 | mPFS 12.3 months mOS 24.6 months 2-year survival rate: 52% |
[123] |
EGFR: EGF receptor; GB: Glioblastoma; id.: Intradermal; im.: Intramuscular; mOS: Median overall survival; mPFS: Median progression-free survival; poly-ICLC: poly-L-lysine and carboxymethyl cellulose; q.d.: Daily; q2 week: Once every 2 weeks; RT: Radiotherapy; t.i.d.: Three times daily; TMZ: Temozolomide.