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Cannabis chemicals join fight against deadly brain tumor

NCT ID NCT03529448

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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