GlioblastomaPhase 1/2AFGBM1NCT04116138
Antisecretory Factor in Primary Glioblastoma 1
A Phase 1/2 study testing Salovum in people with Glioblastoma and Cerebral Edema, run by Peter Siesjö at 1 site in Sweden.
Trial summary
This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Glioblastoma, Cerebral Edema, Chemotherapy Effect
- What is being tested?
- Salovum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2019to 31 Mar 2021
- Phase
- Phase 1/2
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology verified glioblastoma
- Age 18-69 years
- Surgical treatment-biopsy or resection.
- Scheduled full concomitant radiochemotherapy treatment with radiation (60 Gy) and temozolomide,
- Informed consent
Who cannot join
- No informed consent
- Egg yolk allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.
This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.
Read the detailed description
Glioblastoma (GBM) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%.
AF is a 41kilodalton endogenous and essential protein encompassing antisecretory and anti-inflammatory effect. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union.
Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.
In a mouse model of malignant brain tumor, preliminary findings show that intratumoral infusion of AF-16 greatly enhances the effect of simultaneous intratumoral temozolomide treatment (90% and 40% survival, respectively). AF-16 also has preliminarily significant immune modulatory effects on myeloid cells in vitro, but also effects on the secretion of immune modulatory agents from tumor cells. AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.
Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.
Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.
The described study is a safety and feasibility study and if these criteria are fulfilled, will be followed by a randomised controlled trial.
- Conditions
- Glioblastoma, Cerebral Edema, Chemotherapy Effect
- Being tested
- Salovum
- Medical subject headings
- Glioblastoma, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalovumDietary supplement
Also called Antisecretory factor
Egg yolk powder enriched for anti secretory factor
| Study group | Role | What they receive |
|---|---|---|
| Salovum | Experimental | Salovum®, an egg powder enriched for anti secretory factor. Receives: Dietary Supplement: Salovum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse
Treatment related adverse events as assessed by CTCAE v 5.0
Measured: Cumulative from day 1 to 80
Number of participants with completion of prescribed Salovum treatment
Defined as completing prescribed full Salovum treatment
Measured: Cumulative from day 1 to 80
Secondary outcomes (4)
Number of participants with altered blood levels of triglycerides and cholesterol
Blood levels of triglyceride and cholesterol above normal range or increased from baseline
Measured: Change from baseline at day 20, 57 and 70.
Number of participants with reduced or no steroid intake
Intake of oral corticosteroids assessed weekly during and after intervention.
Measured: Change from baseline at day 7, 14, 21, 28, 35, 42, 49, 56, 63 and 70.
Number of participants with detetable blood levels antisecretory factor
Analysis of anti secretory factor-16 (AF-16) blood levels by enzyme linked immunoassay
Measured: Change from baseline at day 20, 57 and 70.
Number of participants with altered blood levels of inflammatory cytokines
Analysis of interleukin-6 (IL-6), interleukin- (IL-8), monocyte chemotactic protein-1 (MCP-1), macrophage inflammatory protein-1a (MIP-1a), macrophage inflammatory protein-1b (MIP-1b) by multiplex analysis
Measured: Change from baseline at day 20, 57 and 70.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1-2, open label, single arm, single center.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Siesjö
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Lund University, Skane University Hospital, Lantmannen Medical AB
- Responsible party
- Sponsor-investigator, Peter Siesjö, Skane University Hospital
- Investigators
- Peter Siesjö, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116138
- Sponsor's protocol ID
- AFGBM1
- Acronym
- AFGBM1
- Status last verified
- Nov 2020
- First submitted
- 26 Sep 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As there are only 5 patients in this study individual patient data without age and gender will be shared after publication
Publications
Ehinger E, Kopecky J, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Belting M, Bengzon J, Siesjo P. Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma. BMC Neurol. 2023 Feb 18;23(1):76. doi: 10.1186/s12883-023-03119-4.
PubMed 36803465
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.
- ClinicalTrials.gov ID
- NCT04116138
- Acronym / sponsor ID
- AFGBM1 / AFGBM1
- Conditions
- Glioblastoma, Cerebral Edema, Chemotherapy Effect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Peter SiesjöUniversity, hospital or other
- Collaborators
- Region Skane, Lund University, Skane University Hospital, Lantmannen Medical AB
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 4 Oct 2019 (actual)
- 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.
This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.
Detailed description
Glioblastoma (GBM) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%.
AF is a 41kilodalton endogenous and essential protein encompassing antisecretory and anti-inflammatory effect. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union.
Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.
In a mouse model of malignant brain tumor, preliminary findings show that intratumoral infusion of AF-16 greatly enhances the effect of simultaneous intratumoral temozolomide treatment (90% and 40% survival, respectively). AF-16 also has preliminarily significant immune modulatory effects on myeloid cells in vitro, but also effects on the secretion of immune modulatory agents from tumor cells. AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.
Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.
Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.
The described study is a safety and feasibility study and if these criteria are fulfilled, will be followed by a randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1-2, open label, single arm, single center.
| Arm | Type | Receives |
|---|---|---|
| Salovum | Experimental | Dietary Supplement: SalovumSalovum®, an egg powder enriched for anti secretory factor. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathology verified glioblastoma
- Age 18-69 years
- Surgical treatment-biopsy or resection.
- Scheduled full concomitant radiochemotherapy treatment with radiation (60 Gy) and temozolomide,
- Informed consent
Key exclusion criteria (2 listed)
- No informed consent
- Egg yolk allergy
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 |
|---|---|---|
| SalovumAlso: Antisecretory factorEgg yolk powder enriched for anti secretory factor | Dietary supplement | Salovum |
Primary outcome
Number of participants with treatment-related adverse
Time frame: Cumulative from day 1 to 80
Treatment related adverse events as assessed by CTCAE v 5.0
Number of participants with completion of prescribed Salovum treatment
Time frame: Cumulative from day 1 to 80
Defined as completing prescribed full Salovum treatment
4 secondary outcomes
Number of participants with altered blood levels of triglycerides and cholesterol
Time frame: Change from baseline at day 20, 57 and 70.
Number of participants with reduced or no steroid intake
Time frame: Change from baseline at day 7, 14, 21, 28, 35, 42, 49, 56, 63 and 70.
Number of participants with detetable blood levels antisecretory factor
Time frame: Change from baseline at day 20, 57 and 70.
Number of participants with altered blood levels of inflammatory cytokines
Time frame: Change from baseline at day 20, 57 and 70.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36803465Ehinger E, Kopecky J, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Belting M, Bengzon J, Siesjo P. Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma. BMC Neurol. 2023 Feb 18;23(1):76. doi: 10.1186/s12883-023-03119-4.
- Individual participant dataSharing planned: Yes. As there are only 5 patients in this study individual patient data without age and gender will be shared after publication
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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.
Peter Siesjö, MD, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Salovum in people with Glioblastoma and Cerebral Edema, run by Peter Siesjö at 1 site in Sweden.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related adverse (time frame: Cumulative from day 1 to 80). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04116138, which also lists 1 linked publication.
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 28 Apr 2021.