Randomisierte, unverblindete, multizentrische klinische Prüfung der Phase I/II zum Vergleich einer Re-Bestrahlung plus einer Gabe von BIBF1120 gegenüber einer alleinigen Re-Bestrahlung zur Behandlung von Patienten mit erster oder zweiter Progression eines Glioblastoms

Phase 1

• Conditions: glioblastoma; MedDRA version: 18.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000921-61-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

- Male and female patients with a recurrence / progression of
glioblastoma either not being eligible for tumour resection or
having macroscopic residual tumor after resection of the
recurrence
- Diagnosis of glioblastoma must be proven histologically and
progress must be documented by MRI. MRI images must not be
older than 2 weeks before first dosing/start of RT
- Not more than two prior therapy regimens including one or two
resections, one or two chemotherapies (one temozolomidecontaining concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumor
- Previous irradiation therapy of the primary tumor with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
- Candidate for reirradiation with recurrent tumor visible on MRIT1 (Gd) and with the largest diameter measuring 1 cm to 5 cm
- Informed consent
- Age = 18 years, smoking or non-smoking, of any ethnic origin
- Karnofsky performance index (KPI) = 60%
- Neutrophile counts > 1500/µl / Platelet counts > 80.000/µl /
Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range
- Adequate contraception
- If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- More than one RT of brain, prior first radiotherapy with more than 60 Gy
- Cumulative total dose on the optical chiasm >54 Gy for 2
Gy/fraction, a/ß=2
- Prior treatment with bevacizumab, iodine seeds and/or
brachytherapy
- Unable to undergo contrast-enhanced MRI
- 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
- HIV or hepatitis infection
- Pregnancy or breast feeding
- Treatment within 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified