Trial document




drksid header

  DRKS00013248

Trial Description

start of 1:1-Block title

Title

Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GlioVax

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The primary objective of the study is to compare overall survival between newly diagnosed glioblastoma patients treated with dendritic cell vaccination as add-on to the standard of care consisting of resection, radiochemotherapy and adjuvant temozolomide (TMZ) chemotherapy and patients treated with the standard of care alone

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013248
  •   2017/11/03
  •   [---]*
  •   yes
  •   Approved
  •   MC-LKP-921, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2017-000304-14 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C71 -  Malignant neoplasm of brain
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Experimental intervention:
    DC vaccination is used as add-on therapy to the control intervention:
    •Fluorescence-guided surgery (day 0)
    •Leukapheresis (wk4)
    •Fractionated radiotherapy (60 Gy: 2 Gy/d, 5/7 d, 6 wks; wk5 10) and concomitant TMZ chemotherapy (75 mg/m2/d; 6 wks; wk5-10)
    •DC vaccination (7x, 2 - 10 x 106 DC each, intradermal injection, weekly wk11-14, wk17, 21, 25)
    •Adjuvant TMZ chemotherapy (150-200 mg/m2/d, 6x, days 1 5 of 28 d cycle: wk15, 19, 23, 27, 31, 35)
  •   Control intervention:
    •Fluorescence-guided surgery (day 0)
    •Fractionated radiotherapy (60 Gy: 2 Gy/d, 5/7 d, 6 wks; wk5 10) and concomitant TMZ chemotherapy (75 mg/m2/d; 6 wks; wk5 10)
    •Adjuvant TMZ chemotherapy (150-200 mg/m2/d, 6x, days 1 5 of 28 d cycle: wk15, 19, 23, 27, 31, 35)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall survival as measured from the day of surgery until death

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

•Progression-free survival as measured from the day of surgery until diagnosis of tumor progression by MRI scan according to modified Response Assessment in Neuro-Oncology (RANO) criteria or death due to any cause
•OS and PFS rates at 6, 12 and 24 months after the day of surgery
•Safety based on the frequency and severity of adverse events (AE) with toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 4.03 (CTCAE 4.03)
•Overall and neurological performance based on the Karnofsky performance status and the Minimal Mental State Examination 2 (MMSE-2)
•Quality of life as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 3.0 and Brain Cancer Module QLQ-BN20 as well as the Distress Thermometer (DT) and the Hospital Anxiety and Depression Scale (HADS) for psycho-oncological strain assessment

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/04/19
  •   136
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

•Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV) confirmed by central neuropathology review
•Near-complete resection (≤ 5 ml residual tumor volume) confirmed by central neuroradiologist on magnetic resonance imaging (MRI) scan within 72 h postoperative
•Karnofsky performance status (KPS) ≥ 70%
•Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production
•Successful production of sterile, avital tumor lysate
•Systemic corticosteroids tapered down to ≤ 2 mg of dexa-methasone or equivalent per day within 7 days postoperative
•Adequate hepatic, liver and bone marrow function and blood coagulation
•Signed informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

•Medical history of severe acute or chronic disease with poor prognosis, autoimmune disorder, immunodeficiency or organ allograft
•Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or Trepo-nema pallidum or other severe infection requiring treatment
•Known allergy or intolerability to components of vaccine, to TMZ or to dacarbazine
•History of bleeding diathesis or coagulopathy
•O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status equivocal

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Heinrich-Heine-Universität Düsseldorf
    • Universitätsstr. 1
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Transplantationsdiagnostik und ZelltherapeutikaUniversitätsklinikum Düsseldorf
    • Mr.  PD Dr. rer. nat.  Rüdiger  Sorg 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Neurochirurgische KlinikUniversitätsklinikum Düsseldorf
    • Mr.  Prof. Dr. med.  Michael C.  Sabel 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Neurochirurgische KlinikUniversitätsklinikum Düsseldorf
    • Mr.  Prof. Dr. med.  Michael C.  Sabel 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.