Glioblastoma Multiforme (first or second progression) MedDRA version: 14.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: APG101
Product Code: APG101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: not assigned
CAS Number: not assigned
Current Sponsor code: APG101
Other descriptive name: Rec
Sponsors
Apogenix GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 •adequate contraception •Stable or decreasing treatment with steroids within 5 days before treatment start •Laboratory results (urine, blood count, chemistry, creatinine) without clinically significant abnormalities or Neutrophile counts > 1 500/µl Platelet counts > 80 000/µl Haemoglobin > 10 g/dl Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: •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 •Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation •Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study •Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study •Pregnancy or breast feeding •Subject is the investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. •Vulnerable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 6 months rate of progression free survival (PFS6) ;Secondary Objective: •Safety and tolerability of APG101 •Progression-free survival •Objective response rates (OR) •Duration of response (DR) in responders •Overall survival •Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20 •Cognitive function determined by MMSE ;Primary end point(s): Primary endpoint is number of patients beeing progression free after 6 month (PFS6). Patients with a confirmed PFS time of at least 6 month will be defined as responders. Progression free survival (PFS) is defined as time from randomization until death or disease progression according to Macdonald criteria. ;Timepoint(s) of evaluation of this end point: At first interims analysis (after 28 patients have been included and treated for 6 month) and at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability of APG101 • Progression-free survival • Objective response rates (OR) • Duration of response (DR) in responders Recurrence pattern analysis • Overall survival • Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20. • Cognitive function determined by MMSE;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Austria, Germany, Russian Federation
Contacts
Public ContactDr. Claudia Kunz
Apogenix GmbH
Outcome results
None listed