NOA-12: BIBF1120 and R-RT in Glioblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Wolfgang Wick, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01666600
First received: July 12, 2012
Last updated: August 21, 2012
Last verified: August 2012
  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.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: BIBF 1120
Radiation: radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Open-label, Multi-centre Study of BIBF1120 + Reirradiation (R-RT) Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I) [ Time Frame: day 0, 8, 15 and 17 post-dose during phase I ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability of BIBF1120 [ Time Frame: Up to 90 days follow-up ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Time from randomization until death or disease progression ] [ Designated as safety issue: No ]
  • Objective response rates (OR) [ Time Frame: Time from randomization until response ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from randomization until death ] [ Designated as safety issue: No ]
  • Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20 [ Time Frame: Screening and 6-weekly after radiotherapy ] [ Designated as safety issue: Yes ]
  • Cognitive function determined by MMSE [ Time Frame: Screening and 6-weekly after end of radiotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 + reirradiation
2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total)
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.
Active Comparator: reirradiation alone
radiotherapy (2 Gy / fraction; 36 Gy in total)
Radiation: radiotherapy
36 Gy, 2 Gy / fraction, 18 fractions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666600

Contacts
Contact: Wolfgang Wick, Prof. Dr. 0049 6221 56 ext 7337 wolfgang.wick@med.uni-heidelberg.de

Locations
Germany
University Hospital Heidelberg, Department of Neurooncology Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Principal Investigator: Wolfgang Wick, Prof. Dr. med.         
University Hospital Heidelberg, Department of Pharmacology Active, not recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Prof. Dr. Wolfgang Wick
  More Information

No publications provided

Responsible Party: Prof. Dr. Wolfgang Wick, Professor Dr. med., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01666600     History of Changes
Other Study ID Numbers: NONK-3/NOA-12
Study First Received: July 12, 2012
Last Updated: August 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 20, 2014