Antisecretory Factor in Primary Glioblastoma 1 (AFGBM1)
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|ClinicalTrials.gov Identifier: NCT04116138|
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Cerebral Edema Chemotherapy Effect||Dietary Supplement: Salovum||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 1-2, open label, single arm, single center.|
|Masking:||None (Open Label)|
|Official Title:||Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.|
|Actual Study Start Date :||October 4, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Salovum®, an egg powder enriched for anti secretory factor.
Dietary Supplement: Salovum
Egg yolk powder enriched for anti secretory factor
Other Name: Antisecretory factor
- 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
- Number of participants with altered blood levels of triglycerides and cholesterol [ Time Frame: Change from baseline at day 20, 57 and 70. ]Blood levels of triglyceride and cholesterol above normal range or increased from baseline
- 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. ]Intake of oral corticosteroids assessed weekly during and after intervention.
- Number of participants with detetable blood levels antisecretory factor [ Time Frame: Change from baseline at day 20, 57 and 70. ]Analysis of anti secretory factor-16 (AF-16) blood levels by enzyme linked immunoassay
- Number of participants with altered blood levels of inflammatory cytokines [ Time Frame: Change from baseline at day 20, 57 and 70. ]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
- Cognitive function [ Time Frame: Change from baseline at day 20, 57 and 70. ]Number of participants with decreased cognitive function assessed by Mini Mental State Examination (MMSE)
- Number of participants with decreased neurological function [ Time Frame: Change from baseline at day 20, 57 and 70. ]Neurologic function assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale. Minimum 0 (no deficits) and maximum 25 (maximum deficits)
- Number of participants with decreased performance [ Time Frame: Change from baseline at day 20, 57 and 70. ]Number of participants with decreased performance assessed by Eastern Oncology Cooperative Group (ECOG) scale. Minum 0 (normal function) and maximum 4 (maximum disability)
- Number of participants with decreased quality of life [ Time Frame: Change from baseline at day 20, 57 and 70. ]Number of participants with decreased quality of life assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and brain cancer module (BN20) questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116138
|Contact: Peter Siesjö, MD, PhDfirstname.lastname@example.org|
|Contact: David Cederberg, MD,||+46 46-17 76 email@example.com|
|Principal Investigator:||Peter Siesjö, MD, PhD||Skane University Hospital|