EUCTR2009-013421-42-DE
Active, not recruiting
Not Applicable
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
ConditionsGlioblastoma Multiforme (first or second progression)MedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioblastoma Multiforme (first or second progression)
- Sponsor
- Apogenix GmbH
- Enrollment
- 83
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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APG101 in glioblastomaGlioblastoma Multiforme (first or second progression)MedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2009-013421-42-ATApogenix GmbH83
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