Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan

Sponsor
CytoVac A/S
Study ID
NCT02060955
Phase
PHASE2
Status
Terminated

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALECSAT — BIOLOGICAL
    The ALECSAT will be administered at week 4, 9, 14, 26 and week 46. Cells are re-suspended in a plasmalyte injection fluid up to a total volume of 20 ml. The 20 ml cell suspension will contain between 10 million and 1 billion cells. Each dose is supplied in a sterile 20 ml syringe and should be injected intravenously.
  • Bevacizumab/Irinotecan — DRUG
    Patients allocated to the Bevacizumab/Irinotecan (control group) will receive treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle consist of 2 dosing days; day 1 and day 15 in the cycle.

Study Details

The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.

Key Dates

Start date
Feb 28, 2014
Status verified
Jun 2016
Primary completion
Jun 30, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alecsat
    The experimental product is an autologous product based on the individual patients blood. Blood donation are performed in study weeks 0, 6, 11, 23 and 43. The patient receives treatment as bolus injection at study weeks 4, 9, 14, 26 and 46.
  • Active Comparator: bevacizumab/irinotecan
    Patients allocated to the comparator arm will be treated in accordance with standard practice in Denmark for relapsed glioblastoma multiforme, up to 16 treatment cycles with 4 weeks duration

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: During the study period up to 62 weeks ]

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