None listed
Conditions
Brief summary
This trial will be assessing Immune-12 as an adjunct treatment to standard care for GBM. Who is it for? You may be eligible to join this study if you are aged 18 years old or above and have a diagnosis of Glioblastoma multiforme (GBM). Have had magnetic resonance imaging (MRI) of their tumour/s within the 4 months prior to Screening Visit. Have a Karnofsky score of equal to or greater than 50 and ability to swallow liquids (Naso-gastric feeding tubes are allowed). Study details All participants who choose to enrol in this study will be asked to take 2 sachets of Immune-12 twice a day for 24 weeks. Participants will be regularly assessed throughout the study for tumour measurement, potential biomarkers, blood markers, quality of life and functionality, steroid usage, inflammation and oedema, and adverse events. It is hoped that the IMMUNE-12 will help reduce disease progression, tumour growth and potential reoccurrence.
Interventions
Immune-12 is produced for human consumption according to the code of Good Manufacturing Practises and Packaging. Immune-12 is manufactured by Unicorn Pacific Marketing Limited and has undergone testing for heavy metals (aluminium, antimony, arsenic, cadmium, calcium, chromium, copper, iodine, iron, lead, magnesium, manganese, mercury, nickel, potassium, selenium, silver, sodium, thallium, tin and zinc) and pathogens (mould, plates, yeast, e.coli, salmonella, t.coliform) prior to release.
Immune-
Immune-12 is produced for human consumption according to the code of Good Manufacturing Practises and Packaging. Immune-12 is manufactured by Unicorn Pacific Marketing Limited and has undergone testing for heavy metals (aluminium, antimony, arsenic, cadmium, calcium, chromium, copper, iodine, iron, lead, magnesium, manganese, mercury, nickel, potassium, selenium, silver, sodium, thallium, tin and zinc) and pathogens (mould, plates, yeast, e.coli, salmonella, t.coliform) prior to release. Immune-12 is not listed on the Pharmaceutical Benefits Scheme (PBS) or the Australian Register of Therapeutic Goods (ARTG.) Sea cucumber Black TeatFish 45%, Sea cucumber Sandfish 40%, Sargassum Seaweed 5%, Sea Sponge 5%, Sea Urchin 5%. The dose is: 2 sachets (10ml per sachet) twice a day for 26 weeks. Adherence will be drug return. GROUP 1: Participants who have completed radiotherapy within the past 4-8 weeks but who have not yet commenced high-dose temozolomide as part of their standard care.
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Equal to or greater than 18 years of age - diagnosis of Glioblastoma multiforme (GBM) - Have had magnetic resonance imaging (MRI) of their tumour/s within the 4 months prior to Screening Visit - Have a Karnofsky score of equal to or greater than 50 (wheelchair bound patients due to paralysis may be considered ambulatory in assessing performance status) - The ability to swallow liquids (Naso-gastric or gastric feeding tubes that allow the administration of Immune-12 are permitted) - Treatment status Group 1 (n=30) - Patients may have undergone biopsy and/or debulking surgery, - have undergone radiation and/or low dose temozolomide (TMZ) treatment, - but have not yet commenced high dose TMZ treatment - the last session of radiation was equal or greater than 4 and equal or greater than 8 weeks ago. Group 2 (n=30) - Patients have completed their course (regardless of the number of cycles within the course) of high-dose monthly TMZ treatment (administered 5 days per month) equal or greater than 4 equal or greater than 16 weeks ago. (That is, the 5th dose of high-dose TMZ in the final cycle of this treatment was taken equal or greater than 4 equal greater than 16 weeks ago, and no further doses of high-dose TMZ have been taken since). These participants may have commenced treatment with Lomustine, Avastin or both, or other treatments selected by the medical oncologist – the IMP can be taken concurrently with these treatments.
Exclusion criteria
Mental Health - Current severe, cognitive impairment (indicated by equal to or greater than 20 on screening Montreal Cognitive Assessment (MOCA) AND confirmation by the PI that the participant lacks the cognitive capacity to consent) Medications - Previous use of Immune-12 in the 2 months prior to Day 0 - Concomitant use of any other clinical trial investigational product for the treatment of GBM Pathology abnormalities - any clinically significant pathology abnormality that indicates trial participation would not be in the person’s best interest, as per PI judgement Other exclusion criteria - Pregnancy, breast-feeding or unwilling to use contraception during the trial - A clinically significant allergy or sensitivity to seafood, sea cucumbers and/or sea molluscs. - Any participant for whom trial participation would not be in the participant’s best interest or whose data would have questionable validity, as per PI discretion
Outcome results
None listed