Condition

Glioblastoma Multiforme (GBM)

Purpose of the study

The present study aims to evaluate the feasibility of Immune-12 as an adjunct treatment for GBM in conjunction with standard medical treatment. ACTRN12624001484538

Official Title

Phase 2 Trial on IMMUNE-12 for high grade gliomas – Glioblastoma Multiforme (GBM).

Who is eligible to participate?

Inclusion criteria

• ≥ 18 years of age
• diagnosis of Glioblastoma multiforme (GBM)
• Have a Karnofsky score of ≥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: Patients may have undergone biopsy and/or debulking surgery; have undergone radiation and/or low dose TMZ treatment but have not yet commenced high dose TMZ treatment.
• Group 2 (n=30): Patient have completed their course of high-dose monthly TMZ treatment (administered 5 days per month). Patient may be on no treatment or may have commenced treatment with Lomustine, Avastin or both, or other treatments selected by the medical oncologist

Exclusion criteria

• Mental Health
  • Current severe, cognitive impairment (indicated by ≤ 20 on screening Montreal Cognitive Assessment (MOCA) AND confirmation by the PI that the participant lacks the cognitive capacity to consent)
• Medications
  • Concomitant use of any other clinical trial investigational product for the treatment of GBM
• Other exclusion criteria
  • Pregnancy, breast-feeding or unwilling to use contraception during the trial
  • A clinically significant allergy or sensitivity to seafood, seaweed, sea cucumbers and/or sea molluscs

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane