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Antisecretory Factor in Primary Glioblastoma 1 (AFGBM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116138
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
Region Skane
Lund University
Skane University Hospital
Lantmannen Medical AB
Information provided by (Responsible Party):
Peter Siesjö, Skane University Hospital

Brief 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 radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.

Condition or disease Intervention/treatment Phase
Glioblastoma Cerebral Edema Chemotherapy Effect Dietary Supplement: Salovum Phase 1 Phase 2

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.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Salovum
Salovum®, an egg powder enriched for anti secretory factor.
Dietary Supplement: Salovum
Egg yolk powder enriched for anti secretory factor
Other Name: Antisecretory factor




Primary Outcome Measures :
  1. 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

  2. Number of participants with completion of prescribed Salovum treatment [ Time Frame: Cumulative from day 1 to 80 ]
    Defined as completing prescribed full Salovum treatment


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathology verified glioblastoma
  2. Age 18-69 years
  3. Surgical treatment-biopsy or resection.
  4. Scheduled full concomitant radiochemotherapy treatment with radiation (60 Gy) and temozolomide,
  5. Informed consent

Exclusion Criteria:

  1. No informed consent
  2. Egg yolk allergy

Information from the National Library of Medicine

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


Contacts
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Contact: Peter Siesjö, MD, PhD +4646171274 peter.siesjo@med.lu.se
Contact: David Cederberg, MD, +46 46-17 76 55 david.cederberg@med.lu.se

Locations
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Sweden
Department of Neurosurgery Recruiting
Lund, Sweden, 22185
Contact: Peter Siesjö, MD, PhD    +4646171274    peter.siesjo@med.lu.se   
Contact: David Cederberg, MD    +46 46-17 76 55    david.cederberg@med.lu.se   
Sponsors and Collaborators
Peter Siesjö
Region Skane
Lund University
Skane University Hospital
Lantmannen Medical AB
Investigators
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Principal Investigator: Peter Siesjö, MD, PhD Skane University Hospital

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Responsible Party: Peter Siesjö, Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT04116138    
Other Study ID Numbers: AFGBM1
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As there are only 5 patients in this study individual patient data without age and gender will be shared after publication
Supporting Materials: Study Protocol
Time Frame: De identified individual patient data will be made available from 3 months after publication up to 24 months after publication
Access Criteria: By request from researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Edema
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Diseases
Glioblastoma
Astrocytoma
Glioma
Central Nervous System Diseases
Nervous System Diseases
Antisecretory factor
Antidiarrheals
Gastrointestinal Agents