Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001484538p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2024
Date registered
19/12/2024
Date last updated
19/12/2024
Date data sharing statement initially provided
19/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 2 Trial on IMMUNE-12 for high grade gliomas - Glioblastoma Multiforme (GBM).
Scientific title
Phase 2 Trial examining IMMUNE-12 for patients with Glioblastoma Multiforme (GBM).
Secondary ID [1] 313306 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GBMI12
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma multiforme 335650 0
Condition category
Condition code
Cancer 332206 332206 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329879 0
Treatment: Drugs
Comparator / control treatment
GROUP 2: participants who have completed their high dose temozolomide treatment in the past 4-16 weeks (regardless of the number of cycles)
Control group
Active

Outcomes
Primary outcome [1] 339791 0
The primary outcome is defined as the difference of response rate on tumour measurements according to the Response Assessment in Neuro-Oncology (RANO) criteria from MRI results (i.e. sum of products of diameters (SPD). Participants will be categorised based on their SPD (i.e. change in SPD (from Screening to final standard-of-care MRI within the trial period) – In the brain or in the brain and spine.
Timepoint [1] 339791 0
Screening then to any standard-of-care MRI performed during the trial period. This includes screening, then approximately week 9, week 18 and week 26, (every 3 months) post intervention commencement
Secondary outcome [1] 441332 0
The difference of response rate on tumour measurements according to the RANO criteria from MRI results (i.e. sum of products of diameters (SPD) from standard-of-care MRIs
Timepoint [1] 441332 0
Screening then to any standard-of-care MRI performed during the trial period. This includes screening, then approximately week 9, week 18 and week 26, (every 3 months) post intervention commencement
Secondary outcome [2] 441333 0
An exploratory outcome will be conducted via identifying potential biomarkers through/of/on the kynurenine pathway to assist in discerning their utility for distinguishing responders from non-responders. e.g. Quinolinic acid (QUIN), picolinic acid (PIC), 3-hydroxyanthranilic acid (3-HAA), L-Kynurenine (KYN).
Timepoint [2] 441333 0
Screening then week 4, week 8, week 12, week 16, week 20 and week 24 post intervention commencement.
Secondary outcome [3] 441334 0
Changes in blood pathology markers: Full blood count
Timepoint [3] 441334 0
Screening, then week 4, week 8, week 12, week 16, week 20, week 24 post intervention commencement.
Secondary outcome [4] 441349 0
Changes in quality of life (QoL) and functionality patient reported outcome called FACT-Br
Timepoint [4] 441349 0
Screening then week 4, week 8, week 12, week 16, week 20, week 24 post commencement of the intervention
Secondary outcome [5] 441350 0
Changes in steroid usage
Timepoint [5] 441350 0
Daily from day 0 to week 24 post intervention commencement
Secondary outcome [6] 441351 0
Changes in brain oedema
Timepoint [6] 441351 0
Approximately three monthly from screening to week 24 post intervention commencement
Secondary outcome [7] 441352 0
Safety via of adverse events (CTCAE v5.0)

Known possible adverse events are nausea and the unpleasant taste of the product.
Timepoint [7] 441352 0
Daily from day 0 to Week 24 post intervention commencement
Secondary outcome [8] 442504 0
Changes in blood pathology markers: renal function.
Timepoint [8] 442504 0
Screening, then week 4, week 8, week 12, week 16, week 20, week 24 post intervention commencement.
Secondary outcome [9] 442507 0
Changes in blood pathology markers: Liver function.
Timepoint [9] 442507 0
Screening, then week 4, week 8, week 12, week 16, week 20, week 24 post intervention commencement.
Secondary outcome [10] 442508 0
Changes in blood pathology markers: blood glucose level
Timepoint [10] 442508 0
Screening, then week 4, week 8, week 12, week 16, week 20, week 24 post intervention commencement.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be via REDCap with a hidden allocation until enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed via SPSS 27.0 and/or R. Analyses will be conducted on an intention-to-treat basis with per-protocol subgroup analysis. Missing data will be imputed by multiple imputation techniques.
Descriptive statistics will summarise data and be presented as either means and standard deviations or medians with interquartile range for continuous data, or absolute and relative frequencies for categorical data.
Outcome measures RANO criteria and FACT-Br will be analysed using ANOVA with repeated measures. The significance level is set at p<0.05. The Bonferroni adjustment or the false discovery rates (FDR) will be applied to adjust the p-values in case of multiple comparisons to control the final type-I errors. Sub-analysis will occur for participants who had a biopsy versus surgical re-section. Molecular phenotype analysis will also be conducted to assess response to the intervention.
Interim analysis
An interim analysis will be conducted once 20 participants completed Week 12.
IMP compliance data
The IMP compliance data will be collated over the trial period and showcased as both absolute and relative frequencies. Compliance data will be used as a covariate for the analysis of the primary and secondary outcomes in ANCOVA and linear regression analyses.
Adverse Event data
Adverse event occurrences will be presented using absolute and relative frequencies, allowing us to quantify the prevalence of events within the dataset. This presentation will be carried out separately for both system organ classes and severity levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
26/02/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 27295 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 27296 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 43384 0
2050 - Camperdown
Recruitment postcode(s) [2] 43385 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 317754 0
Commercial sector/Industry
Name [1] 317754 0
Pacific Marine Biotech Australia Inc
Country [1] 317754 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 320306 0
None
Name [1] 320306 0
Address [1] 320306 0
Country [1] 320306 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316443 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316443 0
Ethics committee country [1] 316443 0
Australia
Date submitted for ethics approval [1] 316443 0
23/09/2024
Approval date [1] 316443 0
Ethics approval number [1] 316443 0
X24-0308 & 2024/ETH02100
Ethics committee name [2] 316444 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [2] 316444 0
Ethics committee country [2] 316444 0
Australia
Date submitted for ethics approval [2] 316444 0
01/10/2024
Approval date [2] 316444 0
Ethics approval number [2] 316444 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137910 0
Dr Janet Schloss
Address 137910 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137910 0
Australia
Phone 137910 0
+61 436101306
Fax 137910 0
Email 137910 0
janet.schloss@scu.edu.au
Contact person for public queries
Name 137911 0
Janet Schloss
Address 137911 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137911 0
Australia
Phone 137911 0
+61 436101306
Fax 137911 0
Email 137911 0
janet.schloss@scu.edu.au
Contact person for scientific queries
Name 137912 0
Janet Schloss
Address 137912 0
Southern Cross University, 1 Military Road, Lismore, NSW 2480
Country 137912 0
Australia
Phone 137912 0
+61 436101306
Fax 137912 0
Email 137912 0
janet.schloss@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently, the IPD will be made available if requested but will not be made available to the public.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.