NOA-12: BIBF1120 and R-RT in Glioblastoma

NCT ID: NCT01666600

Last Updated: 2017-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-09-30

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBF 1120 + reirradiation

2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total)

Group Type: EXPERIMENTAL

BIBF 1120

Intervention Type: DRUG

BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.

reirradiation alone

radiotherapy (2 Gy / fraction; 36 Gy in total)

Group Type: ACTIVE_COMPARATOR

radiotherapy

Intervention Type: RADIATION

36 Gy, 2 Gy / fraction, 18 fractions

Interventions

BIBF 1120

BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.

Intervention Type: DRUG

radiotherapy

36 Gy, 2 Gy / fraction, 18 fractions

Intervention Type: RADIATION

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Wolfgang Wick

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Wolfgang Wick

Professor Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital Heidelberg, Department of Neurooncology

Heidelberg, Baden-Wurttemberg, Germany

University Hospital Heidelberg, Department of Pharmacology

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

NONK-3/NOA-12

Identifier Type: -

Identifier Source: org_study_id