The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma
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
Study ID: NCT03529448
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario Virgen del Rocío, Sevilla, Andalucia, Spain
Institut Català d'Oncología L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Son Espases, Palma de Mallorca, Mallorca, Spain
Hospital del Mar, Barcelona, , Spain
Complejo Hospitalario Regional Virgen de las Nieves, Granada, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Name: Manuel Benavides, M.D., Ph.D.
Affiliation: Hospital Universitario y Regional de Málaga y Virgen de la Victoria
Role: PRINCIPAL_INVESTIGATOR