Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan
|ClinicalTrials.gov Identifier: NCT02060955|
Recruitment Status : Terminated (Substantial design modifications required.)
First Posted : February 12, 2014
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Biological: ALECSAT Drug: Bevacizumab/Irinotecan||Phase 2|
This study is an open-label, randomized, prospective, parallel group phase II study with ALECSAT compared to Bevacizumab/Irinotecan in patients with verified relapsed glioblastoma multiforme after or during treatment with recognised first-line treatment. After 62 PFS events have been recorded, an interim analysis will be conducted under the auspices of the Data Monitoring Committee.
The patients in the two treatment groups will be followed for up to 62 weeks by planned study visits. Patients with, at least, stable disease will continue the allocated treatment after the study period as judged by the Investigator. Patients allocated to the Bevacizumab/Irinotecan (control group) will receive their treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle of Bevacizumab/Irinotecan consist of 2 dosing days; day 1 and day 15 in the cycle.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||July 2015|
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.
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.
Other Name: ALECSAT, the investigational product,
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
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.
- Progression-free survival (PFS) [ Time Frame: During the study period up to 62 weeks ]To compare progression-free survival (PFS) in patients with relapsed GBM when the patients are either treated with ALECSAT immunotherapy or standard praxis therapy with Bevacizumab/Irinotecan. Progression of disease is defined according to the response evaluation criteria for solid tumours (RANO)
- Overall survival (OS) [ Time Frame: During the study period up to 62 weeks ]To evaluate the overall survival (OS) during the study period in patients treated with ALECSAT compared to patients treated with Bevacizumab/Irinotecan by Kaplan-Meier methodology
- Time to progression (TTP) [ Time Frame: During the study period up to 62 weeks ]To evaluate time to progression in the two treatment groups To compare PFS in the two treatment groups by Kaplan-Meier methodology upon study completion To compare PFS in a landmark analysis in the two treatment groups after a duration of 6 and 12 months after initiation of treatment
- Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) questionnaire [ Time Frame: During the study period up to 62 weeks ]To investigate QoL and performance status during the study period for patients treated with ALECSAT compared to patients treated with Avastin/Irinotecan
- Overall Response Rate (ORR) [ Time Frame: During the study period up to 62 weeks ]To compare Objective Response Rate (ORR)
- Safety & tolerability [ Time Frame: During the study period up to 62 weeks ]Comparison of type and frequency of AEs; changes in biochemical parameters of clinical relevance; in hematology parameters of clinical relevance; in vital signs and change in electrocardiogram (ECG). Evaluation of medical events of special interest.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060955
|Aalborg Universityhospital, Department of Oncology|
|Aalborg, Hobrovej 18-22, Denmark, 9000|
|Aarhus University Hospital, Department of Oncology|
|Aarhus, Nørrebrogade 44, Denmark, 8000|
|Odense University Hospital, Department of Oncology|
|Odense, Sdr. Boulevard 29, Denmark, 5000|
|Department of Oncology, Rigshospitalet|
|Copenhagen, Denmark, DK-2100|
|Study Director:||Martin Roland Jensen, PhD||CytoVac A/S (Sponsor)|