Completed

GEINOCANNSafety Assessment of THC+CBD Combination with Temozolomide and Radiotherapy in Newly-Diagnosed Glioblastoma

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Study Aim

This study aims to evaluate the safety and determine the maximum tolerated dose of THC+CBD combination when used with Temozolomide and Radiotherapy in individuals newly-diagnosed with Glioblastoma, focusing on the incidence of treatment-related adverse events.

What is being tested

TN-TC11G

+ Temozolomide Oral Product

+ Radiotherapy

DrugRadiation
Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

From 18 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2023
See protocol details

Summary

Principal SponsorGrupo Español de Investigación en Neurooncología
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 18, 2023

Actual date on which the first participant was enrolled.

Glioblastoma is a serious type of brain tumor with a poor outlook, despite using the most advanced treatments available. The standard treatment after surgery involves a combination of chemotherapy with temozolomide and radiotherapy, followed by additional chemotherapy cycles. However, survival rates have not significantly improved in the last decade. Recent research suggests that two compounds found in cannabis, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), may enhance the effects of temozolomide and radiotherapy in fighting glioma tumors. These compounds interact with specific receptors in the brain and immune system, triggering a response that can lead to the destruction of tumor cells. The Spanish Group for Neuro-oncology (GEINO) is conducting a study to evaluate the safety of combining THC and CBD with temozolomide and radiotherapy in patients newly diagnosed with glioblastoma. This study is a phase Ib, open-label, multicenter trial that will involve 30 patients over a 6-month period at 8 specialized neuro-oncology centers. The goal is to determine the safety and maximum tolerated dose of the THC-CBD combination when used with temozolomide and radiotherapy. Participants will receive a combination of THC and CBD in a 1:1 ratio, with the dose gradually increasing. The study will monitor the type and number of adverse events during the treatment period, using established criteria to classify these events. The study will also determine the recommended dose of the THC-CBD combination to be used with temozolomide during and after radiotherapy.

Official TitlePhase Ib, Open-label, Multicenter, Intrapatient Dose-escalation Clinical Trial to Assess the Safety Profile of the TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma
NCT03529448
Principal SponsorGrupo Español de Investigación en Neurooncología
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

7 inclusion criteria required to participate
Ability to understand and sign the informed consent document
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).
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.
Show More Criteria
4 exclusion criteria prevent from participating
Previous abuse of cannabinoids.
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.
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.
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
During Phase Ib, Four to seven weeks after surgical diagnosis, concurrent with radiotherapy (STUPP) \+ temozolomide (75mg/m2/day for 42 days) +TN-TC11G will be evaluated. During radiation therapy, temozolomide and TN-TC11G will be administered. This last, as the dose that have been selected previously, based on dose-titration period. Patient specific dose will remain until progresion of disease, unacceptable toxicity, non-compliance, consent withdrawal up to 2 years.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Hospital Universitario Virgen del Rocío

Seville, SpainOpen Hospital Universitario Virgen del Rocío in Google Maps
Suspended

Hospital del Mar

Barcelona, Spain
Suspended

Institut Català d'Oncología L'Hospitalet

L'Hospitalet de Llobregat, Spain
Suspended

Hospital Universitario Son Espases

Palma de Mallorca, Spain
Completed8 Study Centers