Antisecretory Factor Glioblastoma Phase 2

Glioblastoma Clinical Trial

— AFGB2  

Official title:

Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669820
• Other study ID #: FPAFGB2ver6
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 15, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Skane University Hospital
• Contact: Peter Siesjö, MD, PhD
• Phone: +4646171274
• Email: peter.siesjo[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis

Description:

Glioblastoma (GB) 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 with antisecretory and anti-inflammatory effects. 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 an din other countries.

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.

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.

Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.

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.

In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.

The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Pathology verified glioblastoma or astrocytoma grade 4

2. Age 18-75 years

3. Surgical treatment-resection.

4. Scheduled concomitant radiochemotherapy, or only chemotherapy.

5. Informed consent

Exclusion Criteria:

1. No informed consent

2. Egg yolk allergy

3. Only surgical biopsy

4. Only radiotherapy

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Dietary Supplement:
• Salovum
Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor.
• Placebo egg yolk powder
Egg yolk powder derived from hen fed with normal feed.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Peter Siesjö	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	Assessed by Montreal Cognitive Assessment (MoCA)	up to 1 year
Other	Neurological function	Assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale	up to 1 year
Other	QOL Assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30	Assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 questionnaire	up to 1 years
Other	quality of life (QOL) assessed by brain cancer module (BN20) questionnaire	Assessed by brain cancer module (BN20) questionnaire	up to 1 years
Other	Performance Assessed by Eastern Oncology Cooperative Group (ECOG) performance scale	Assessed by Eastern Oncology Cooperative Group (ECOG) performance scale	up to 1 year
Primary	Overall survival	Survival	up to 12 months from primary surgery
Secondary	Progress free survival at 6 and 12 months	Progress free survival as a compound assessment by a multidisciplinary conference (MDC)	At 6 and 12 months from primary surgery