Glioblastoma MultiformePhase 2NCT02060955
Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan
A Phase 2 study testing ALECSAT and Bevacizumab/Irinotecan in people with Glioblastoma Multiforme, run by CytoVac A/S at 4 sites in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ALECSAT and Bevacizumab/Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesDenmark
- Study dates
- Feb 2014to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI,
- Minimum age of 18 years old,
- Capable of understanding the information and giving informed consent
- Minimum height of 155 cm
- Expected survival time (life expectancy) of over 3 months
- Adequate performance status equal or below 2
- Clinically normal Erythrocyte Volume Fraction (EVF)
- Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study
Who cannot join
- Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis)
- Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
- Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
- Clinically significant autoimmune disorders or conditions of immune suppression
- Hemoglobin count ≤ 7.5mmol/l (men \& women)
- Lymphocyte-numbers below 0.5 x 109/l
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- Body weight below 40 kg (men) and 50 kg (women)
- Clinically abnormal ECG as judged by the Investigator
- Pregnant or breast feeding women
- Inclusion in other clinical studies 4 weeks prior to inclusion in the study
- Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
- Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
- Patients that either may be put at risk due to the blood donation or where it is not expected that an ALECSAT product of good quality can be produced, as judged by the Investigator
- Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection
- Blood transfusions within 48 hours prior to donation of blood for ALECSAT production
- Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombinant humanized antibodies Performance status ≥ 3
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg Universityhospital, Department of Oncology
Aalborg, Hobrovej 18-22, 9000
Aarhus University Hospital, Department of Oncology
Aarhus, Nørrebrogade 44, 8000
Department of Oncology, Rigshospitalet
Copenhagen, DK-2100
Odense University Hospital, Department of Oncology
Odense, Sdr. Boulevard 29, 5000
About this study
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
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.
Read the detailed description
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ALECSAT, Bevacizumab/Irinotecan
- Keywords
- Glioblastoma multiforme, Immunotherapy, Bevacizumab/Irinotecan, ALECSAT, recurrent
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALECSATBiological
Also called ALECSAT, the investigational product,
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/IrinotecanDrug
Also called Bevacizumab, Irinotecan
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 group | Role | What they receive |
|---|---|---|
| Alecsat | Experimental | 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. Receives: Biological: ALECSAT |
| bevacizumab/irinotecan | Active comparator | 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 Receives: Drug: Bevacizumab/Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
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)
Measured: During the study period up to 62 weeks
Secondary outcomes (4)
Overall survival (OS)
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
Measured: During the study period up to 62 weeks
Time to progression (TTP)
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
Measured: During the study period up to 62 weeks
Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) questionnaire
To investigate QoL and performance status during the study period for patients treated with ALECSAT compared to patients treated with Avastin/Irinotecan
Measured: During the study period up to 62 weeks
Overall Response Rate (ORR)
To compare Objective Response Rate (ORR)
Measured: During the study period up to 62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: Substantial design modifications required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoVac A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Roland Jensen, PhD, Study director, CytoVac A/S (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060955
- Sponsor's protocol ID
- CV-005
- Status last verified
- Jun 2016
- First submitted
- 10 Feb 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02060955
- Acronym / sponsor ID
- CV-005
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma multiforme, Immunotherapy, Bevacizumab/Irinotecan, ALECSAT, recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Substantial design modifications required.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CytoVac A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alecsat | Experimental | Biological: ALECSATThe 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. |
| bevacizumab/irinotecan | Active comparator | Drug: Bevacizumab/IrinotecanPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI,
- Minimum age of 18 years old,
- Capable of understanding the information and giving informed consent
- Minimum height of 155 cm
- Expected survival time (life expectancy) of over 3 months
Key exclusion criteria (16 listed)
- Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis)
- Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative
- Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
- Clinically significant autoimmune disorders or conditions of immune suppression
- Hemoglobin count ≤ 7.5mmol/l (men \& women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALECSATAlso: ALECSAT, the investigational product,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. | Biological | Alecsat |
| Bevacizumab/IrinotecanAlso: Bevacizumab, IrinotecanPatients 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. | Drug | bevacizumab/irinotecan |
Primary outcome
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)
4 secondary outcomes
Overall survival (OS)
Time frame: During the study period up to 62 weeks
Time to progression (TTP)
Time frame: During the study period up to 62 weeks
Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) questionnaire
Time frame: During the study period up to 62 weeks
Overall Response Rate (ORR)
Time frame: During the study period up to 62 weeks
Results and safety
The study was stopped early (reason given: Substantial design modifications required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Roland Jensen, PhD study director
CytoVac A/S (Sponsor)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALECSAT and Bevacizumab/Irinotecan in people with Glioblastoma Multiforme, run by CytoVac A/S at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Substantial design modifications required.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: During the study period up to 62 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.