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New treatment option for Glioblastoma
Official title ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
ClinicalTrials.gov ID: NCT05629702
What this study is testing
What is Nabiximols?
Nabiximols is an investigational medicine, given as an once-weekly, being studied as a potential treatment for glioblastoma.
Also referred to as Sativex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is...
- First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant...
- Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or...
- A minimum of 3 cycles of adjuvant TMZ must have been received.
- A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line treatment (measured by Response...
You likely can't join if
- Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
- Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.
- Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.
- Prior treatment, apart from debulking surgery, for first recurrence of GBM.
- Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.
- Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than...
See the full eligibility criteria
- Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).
- First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence...
- Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in...
- A minimum of 3 cycles of adjuvant TMZ must have been received.
- A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria).
- ≥3 months since day 28 of the last cycle of TMZ.
- Karnofsky Performance Status ≥60.
- Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Serum creatinine clearance (measured or calculated (using local standard practice)) \>30ml/min
- Total serum bilirubin ≤1.5 x upper limit of normal (ULN)
- Liver transaminases \<2.5 x ULN
- If surgery has been performed for first recurrence, then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow up deemed...
- Recovered from previous treatment side-effects ≤ Grade 2.
- If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids.
- Willing and able to provide trial-specific informed consent.
- Willing and able to comply with trial requirements.
- Age ≥16.
- Able to start treatment within 28 days of randomisation.
- Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
- Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.
- Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.
- Prior treatment, apart from debulking surgery, for first recurrence of GBM.
- Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.
- Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.
- Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.
- Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and/or unwilling to abstain for the duration of the trial.
- Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment. o Women of...
- Men who are sexually active and unwilling/unable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.
- Contra-indication to MRI or gadolinium.
- Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Known hypersensitivity to cannabinoids or excipients of the IMP.
- Known history of current or prior alcohol or drug dependence.
- Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.
- Has received a live vaccine within 28 days prior to randomisation.
- Unable to administer oromucosal medication due to mucosal lesions or other issues.
- Participation in another therapeutic clinical trial whilst taking part in this trial.
- Any psychological, familial, sociological or geographical condition hampering protocol compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Bodelwyddan, Denbighshire, United Kingdom
- Northwood, Middlesex, United Kingdom
- Aberdeen, United Kingdom
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Hull, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Maidstone, United Kingdom
- Manchester, United Kingdom
- Metropolitan Borough of Wirral, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bodelwyddan, Denbighshire, United Kingdom; Northwood, Middlesex, United Kingdom; Aberdeen, United Kingdom; Belfast, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.