From: Targeting autophagy to sensitive glioma to temozolomide treatment
Studys | Type | Year of registration | Sponsor | Drugs | Tumor type | Targeted enrolment | Status | Major findings |
---|---|---|---|---|---|---|---|---|
NCT00486603 [41] | Phase I | 2007 | Sidney Kimmel Comprehensive Cancer Center | 200, 400, 800 mg/day HCQ + 150-200 mg/m2/day TMZ for 5 d [q4wk] + RT | Newly diagnosed GBM | 16 | Complished | HCQ 600 mg/day was found to be the MTD in this combination. |
NCT00486603 [41] | Phase II | 2007 | Sidney Kimmel Comprehensive Cancer Center | 600 mg/day HCQ + 150-200 mg/m2/day TMZ for 5 d [q4wk] + RT | Newly diagnosed GBM | 76 | Complished | Median survival of 15.6 mos with survival rates at 12, 18, and 24 mo of 70%, 36%, and 25%. PK analysis indicated dose-proportional exposure for hCQ. AV in PBMC: patients with Cmax above 1785 ng/mL had a increased median AV change of 1.01. |
NCT02378532a | Phase I | 2015 | Maastricht Radiation Oncology | 200-600 mg/day HCQ + 150-200 mg/m2/day TMZ for 5 d [q4wk] + RT | Newly diagnosed GBM | 9 | Not yet open | N/A |
NCT01430351a | Phase I | 2011 | M.D. Anderson Cancer Center | 250 mg/day MFQ for 3 d/week+ 150 mg/m2/day TMZ for 5 d [q4wk] | Post-RT Glioblastoma | 144 | Recruiting participants | N/A |