Cancer types
  • Neuro-oncology
Title of study
A phase I trial for the addition of chloroquine, an autophagy inhibitor, to concurrent chemoradiation for newly diagnosed glioblastoma
Version Number
Approval Date 
6.0, 9 May 2016
Short Title
Chloroquine GBM
Study site
Principle Investigator
prof. dr. Ph. Lambin
Investigator Maastro
Drs. I. Compter
Sponsor
prof. dr. Ph. Lambin
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

To determine the MTD/RPTD for CQ in combination with concurrent radiotherapy with daily TMZ in patients with a newly diagnosed GBM

Primary Endpoint 

Incidence of dose-limiting toxicities

Secondary Endpoints 

• Adverse Events (AEs), serious AEs (SAEs), changes in haematology and chemistry values, vital signs, electrocardiograms, tone audiograms or ophthalmologic examination.
• Pharmacokinetics of CQ
• Presence of autophagic marker (LC3b)
• Gene mutation, deletion or amplification such as MGMT, EGFRvIII in tumor tissue pre-treatment
• Radiological response on follow-up MRI
• Time from inclusion until death from any cause
• Time from inclusion until disease progression or death