Cannabis chemicals join fight against deadly brain tumor
NCT ID NCT03529448
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested whether adding THC and CBD (cannabinoids from cannabis) to standard chemotherapy and radiation is safe for people with newly diagnosed glioblastoma, an aggressive brain cancer. Thirty-three patients received gradually increasing doses of the cannabinoid combination alongside their usual treatment. The main goal was to find the highest safe dose and track any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- THC (tetrahydrocannabinol) and CBD (cannabidiol) combined with temozolomide and radiotherapy
- What this could lead to
- If it works, this could point toward a new way to improve standard treatment for glioblastoma, potentially extending survival.
- What could go wrong
- This is an early, small trial (33 people) focused on safety, not effectiveness. The added cannabinoids may not improve outcomes and could cause side effects like dizziness or fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
33 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
-
Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to understand and sign the informed consent document * Men or women ≥18 years and ≤70 years * Newly-diagnosed GB confirmed by biopsy or by resection in the 4-7 weeks before being registered in the trial. * Patients must have at least 15 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived). * Patients must have recovered from previous surgeries (time between surgery and inclusion in the study: 6 weeks). * Karnofsky Index ≥60%. * Adequate bone marrow reserve: haemoglobin ≥10 g/dL, WBC \>3,000/mcL, absolute neutrophil count (ANC) ≥1,500 cells/μL, platelets ≥100,000 cells/μL. * Adequate liver function: Bilirubin \<1.5 times the upper limit of normal (ULN); AST ≤2.5 x ULN * Creatinine clearance \>60 ml/min/1.73 m2. * The study treatment's effects on the development of the human foetus are not known. For this reason, women of childbearing age and men must agree to use a suitable birth control method (hormonal, barrier, abstinence or surgical sterilisation) before inclusion in the study, for the duration of the study and for at least 3 months after completing the trial treatment. The definition of an effective method of birth control is based on the judgement of the principal investigator or their designee. If a woman is pregnant or there is suspicion that she might be pregnant while participating in the study, she must inform the trial doctor immediately. All women of childbearing age should have a negative pregnancy test (serum/urine) in the 2 weeks prior to the beginning of treatment. Exclusion Criteria: * Presence of extracranial metastatic disease. * Any previous treatment for glioblastoma. * Patients who have had a Gliadel implant in the surgery. * Use of an enzyme-inducing antiepileptic drug. Patients receiving this type of drug must have a washout period of at least 7 days prior to study inclusion. * Previous abuse of cannabinoids. * Presence of any clinically significant gastrointestinal abnormality that may affect the intake, transit or absorption of the study drug, such as the inability to take medication in the form of oral tablets or solution. * Presence of any psychiatric or cognitive impairment that limits understanding or the signing of the informed consent and/or compromises compliance with the requirements of this protocol. * Significant or uncontrolled cardiovascular disease, including: 1. Myocardial infarction in the previous 12 months. 2. Uncontrolled angina in the previous 6 months. 3. Congestive heart failure in the previous 6 months. 4. Diagnosed or suspected congenital long QT syndrome. 5. History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes). 6. QTc prolongation on an electrocardiogram prior to entry (\>470 ms). 7. History of second- or third-degree heart block (these patients may be eligible if they carry pacemakers). 8. Heart rate \<50/min on the baseline electrocardiogram. 9. Uncontrolled hypertension * Any patient with a history of significant cardiovascular disease, even if it is currently controlled, or who presents signs or symptoms that suggest impaired left ventricular function according to the investigator should have an assessment of left ventricular ejection fraction (LVEF) by ECCO or MUGA. If the LVEF in these circumstances is below the site's lower limit of normality or less than 50%, the patient will not be eligible. * History of any cancer, except in the following circumstances: Patients with a history of other malignancies are eligible if they have been disease-free for at least the last 3 years and if, in the investigator's opinion, there is a low risk of disease recurrence. People with the following cancers are eligible, even if they have been diagnosed and treated in the past 3 years: cervical carcinoma in situ and basal cell carcinoma. Patients will not be eligible if there is evidence of another cancer that required therapy other than surgery in the past 3 years.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Complejo Hospitalario Regional Virgen de las Nieves
Granada, 18004, Spain
-
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
-
Hospital Regional Universitario de Malaga
Málaga, Spain
-
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
-
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain
-
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013, Spain
-
Hospital del Mar
Barcelona, 08003, Spain
-
Institut Català d'Oncología L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients
- Breathing CO2 during brain scans could reveal hidden tumor disruption
- Can an oral drug that starves tumors help Hard-to-Treat cancers?
- Can repeated MRI scans reveal how tumors respond to radiation?