Phase Ib Clinical Trial to Evaluate the Safety Profile of the Combination Tilray FS Oral Solution T10:C10 with Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma.
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- 2024-515546-16-00
- Lead Sponsor
- Grupo Espanol De Investigacion En Neurooncologia
- Brief 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 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TN-TC11G, radiotherapy and Temozolomide Oral Product Temozolomide Oral Product 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. TN-TC11G, radiotherapy and Temozolomide Oral Product Radiotherapy 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. TN-TC11G, radiotherapy and Temozolomide Oral Product TN-TC11G 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.
- Primary Outcome Measures
Name Time Method THC-CBD Maximum tolerated dose 9 weeks After intra-patient dose escalation period, recommended dose of Glasdegib administeres with temozolamide during and after RT.
Incidence of Treatment-Emergent Adverse Events 12 months Type and number or adverse events reported during THC-CBD treatment, based on the CTCAE reference criteria.
- Secondary Outcome Measures
Name Time Method Antitumor activity of THC-CBD combination with temozolamide and radiotherapy 12 months Based on the tumor response in patients with measurable disease, after comparison of baseline characteristics and follow-up evaluations
Overall survival 12 months Time between the start of treatment to death
Progression free survival 12 months Time between the start of treatment and progression of disease
Expression of Midkine 12 months Correlation of expression of midkine in peripheral blood and response to the experimental treatment.
Trial Locations
- Locations (8)
Ajuntament De L Hospitalet De Llobregat
🇪🇸L'hospitalet De Llobregat, Spain
Hospital Universitario De Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Virgen De Las Nieves
🇪🇸Granada, Spain
Hospital Universitario Regional De Malaga
🇪🇸Malaga, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
University Hospital Son Espases
🇪🇸Palma, Spain
University Hospital Virgen Del Rocio S.L.
🇪🇸Sevilla, Spain
Ajuntament De L Hospitalet De Llobregat🇪🇸L'hospitalet De Llobregat, SpainAgostina StradellaSite contact+34934344412investigacion@mfar.net