A phase II, randomized, open-label, multi-centre study of weekly APG101 + reirradiation versus reirradiation in the treatment of patients with first or second progression of glioblastoma - APG101 in glioblastoma

Apogenix GmbH0 sites83 target enrollmentDecember 15, 2009

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Signed Informed Consent
•Male and female patients with a local recurrence / progression of glioblastoma and either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence
•Not more than two prior therapy regimens including one or two resections, one or two chemotherapies, of which one must have been TMZ\-containing and one radiotherapy for the brain tumour
•Diagnosis of glioblastoma must be proven histologically and progress / recurrence of glioblastoma must be documented by MRI. MRI images must not be older than 2 weeks before randomisation / start of RT
•Candidate for reirradiation with recurrent tumour visible on MRI\-T1 (Gd) and with the largest diameter measuring 1 to 4 cm
•Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy
•At least 8 months since the end of preirradiation
•at least 18 years old, smoking or non\-smoking, of any ethnic origin
•Karnofsky performance index (KPI) \= 60%
•Suitable veins or existing port system for intra\-venous infusion

•Unable to give informed consent for this study
•Unable to undergo MRI
•Prior second radiotherapy of brain, prior first radiotherapy with more than 60 Gy
•Prior treatment with bevacizumab
•Prior treatment with iodine seeds and brachytherapy
•Doses to organs at risk defined by Dogan et al. (2003\) exceeded or reached by prior radiation therapy; e.g. cumulative total dose on the optical chiasm \>54 Gy for 2 Gy/fraction, a/ß\=2
•Treatment within in any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion
•Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III – IV)
•Positive test results for HbsAG, anti\-HCV, anti\-HIV\-1/\-2
•Any other condition or treatment that, in the opinion of the Investigator, might interfere with the study or current drug or substance abuse