NOA-12: BIBF1120 and R-RT in Glioblastoma

Prof. Dr. Wolfgang Wick

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Glioblastoma Multiforme

Treatments

Drug: BIBF 1120

Radiation: radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01666600

NONK-3/NOA-12

Details and patient eligibility

About

Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour 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 temozolomide containing concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumour
Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
Candidate for reirradiation with recurrent tumour 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

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, α/β=2
Prior treatment with bevacizumab, iodine seeds and/or brachytherapy
Unable to undergo 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)