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NOA-12: BIBF1120 and R-RT in Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01666600
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Prof. Dr. Wolfgang Wick
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Terminated
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: BIBF 1120 + reirradiation

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

Active Comparator: reirradiation alone

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

Interventions

Drug: - 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.

Radiation: - radiotherapy

36 Gy, 2 Gy / fraction, 18 fractions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Heidelberg, Baden-Württemberg, Germany

Status

Address

University Hospital Heidelberg, Department of Neurooncology

Heidelberg, Baden-Württemberg, 69120

Heidelberg, Baden-Württemberg, Germany

Status

Address

University Hospital Heidelberg, Department of Pharmacology

Heidelberg, Baden-Württemberg, 69120

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