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GlioblastomaPhase 1/2GEINOCANNNCT03529448

TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma

A Phase 1/2 study testing TN-TC11G, Temozolomide Oral Product and Radiotherapy in people with Glioblastoma, run by Grupo Español de Investigación en Neurooncología at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Glioblastoma is the primary brain tumour with the worst prognosis: median survival is only 12 months despite the use of the most advanced treatments. In the past 10 years, survival in the treatment of this disease has not advanced significantly, with the postoperative standard being the administration of… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma
What is being tested?
TN-TC11G, Temozolomide Oral Product and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesSpain
Study dates
18 Aug 2023to 13 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital del Mar

    Barcelona, 08003

  • Complejo Hospitalario Regional Virgen de las Nieves

    Granada, 18004

  • Institut Català d'Oncología L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Malaga

    Málaga

  • Hospital Universitario Son Espases

    Palma de Mallorca, Mallorca

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocío

    Seville, Andalusia, 41013

Other trials in Spain

About this study

Official title: Phase 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

Glioblastoma is the primary brain tumour with the worst prognosis: median survival is only 12 months despite the use of the most advanced treatments. In the past 10 years, survival in the treatment of this disease has not advanced significantly, with the postoperative standard being the administration of chemoradiotherapy with temozolomide, followed by 6 cycles of sequential chemotherapy with temozolomide.

Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) have shown a clear synergistic antitumour effect with temozolomide and radiotherapy in preclinical glioma models. THC and CBD have a wide variety of biological effects by binding with and activating the type 1 and type 2 cannabinoid receptors (CB1 expressed in certain neuronal areas of the brain and CB2 expressed in the immune system and in glial cells). The activation of these receptors initiates a signalling pathway, called the endoplasmic reticulum stress response, which generates tumour cell autophagy by activating TRB3.

Read more

Given these data, the Spanish Group for Neuro-oncology (GEINO) proposes developing a phase Ib, open-label, multicenter, intrapatient dose-escalation clinical trial to assess the safety profile of the THC+CBD combination at a 1:1 ratio, adding temozolomide and radiotherapy in patients with newly-diagnosed glioblastoma.

The number of patients to be recruited is 30 over 6 months at 8 sites specialising in neuro-oncology.

Conditions
Glioblastoma
Being tested
TN-TC11G, Temozolomide Oral Product, Radiotherapy
Keywords
Glioblastoma
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TN-TC11GDrug

    TN-TC11G dose will be gradually increased as follows:

    Week 1: TN-TC11G: 0-0-5 mg (THC 5 mg + CBD 5 mg; in the mornings, 90 minutes after breakfast; in the afternoons, 90 minutes after lunch; in the evenings, 90 minutes after dinner).

    Week 2: TN-TC11G: 5-0-5 mg Week 3: TN-TC11G: 5-5-5 mg Week 4: TN-TC11G: 5-5-10 mg Week 5: TN-TC11G: 5-5-15 mg Week 6: TN-TC11G: 10-10-15 mg Week 7: TN-TC11G: 10-10-20 mg. Week 8: TN-TC11G: 15-15-30 mg Week 9: TN-TC11G: 20-20-40 mg TN-TC11G will be administered daily at the relevant dose level according to the individual titration performed in the first 9 weeks of treatment. If there is any dose reduction, the reduced dose must be administered.

  • Temozolomide Oral ProductDrug

    Also called Temozolomide

    During RT, patients will receive Temozolomide (TMZ). All patients will be given TMZ at 75 mg/m2/d concurrently with RT for a maximum of 42 days.

    At 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles.

  • RadiotherapyRadiation

    Also called STUPP

    All the patients will receive the Stupp regimen. The radiotherapy (RT) treatment will be administered in fractions of 1.8-2.0 Gy/day delivered 5 days/week to a total dose of 58-60 Gy. Radiotherapy will be delivered to the gross tumor volume with a 2-3 cm margin for the clinical target volume.

Study groups in NCT03529448
Study groupRoleWhat they receive
TN-TC11G, radiotherapy and Temozolomide Oral ProductExperimentalDuring 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.
Receives: Drug: TN-TC11G; Drug: Temozolomide Oral Product; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. THC-CBD Maximum tolerated dose

    After intra-patient dose escalation period, recommended dose of Glasdegib administeres with temozolamide during and after RT.

    Measured: 9 weeks

  2. Incidence of Treatment-Emergent Adverse Events

    Type and number or adverse events reported during THC-CBD treatment, based on the CTCAE reference criteria.

    Measured: 12 months

Secondary outcomes (4)

  1. Antitumor activity of THC-CBD combination with temozolamide and radiotherapy

    Based on the tumor response in patients with measurable disease, after comparison of baseline characteristics and follow-up evaluations

    Measured: 12 months

  2. Overall survival

    Time between the start of treatment to death

    Measured: 12 months

  3. Progression free survival

    Time between the start of treatment and progression of disease

    Measured: 12 months

  4. Expression of Midkine

    Correlation of expression of midkine in peripheral blood and response to the experimental treatment.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start18 Aug 2023
  3. Primary completion13 Nov 2025
  4. Study completion13 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Phase Ib, intra-patient dose escalation trial.
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529448
Sponsor's protocol ID
GEINO-1601
Other IDs
2016-003216-12, 2016
Acronym
GEINOCANN
Status last verified
Feb 2026
First submitted
23 Apr 2018
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TN-TC11G, Temozolomide Oral Product and Radiotherapy in people with Glioblastoma, run by Grupo Español de Investigación en Neurooncología at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

THC-CBD Maximum tolerated dose (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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