
Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients
Study Purpose
Glioblastoma is the most common and the most aggressive primary brain cancer in adults. Indeed, despite very intensive treatments (i.e. maximal safe surgery, radiotherapy and several lines of cytotoxic chemotherapies), inducing significant adverse events, the prognosis of glioblastoma patients remains dismal with a median overall survival of ~15 months. Therefore, more efficient and less toxic therapies are urgently needed to improve survival and quality of life of glioblastoma patients. The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude mice). Comprehensive toxicology studies of TG6002/Flucytosine have been completed in rabbits and monkeys supporting safety investigations of TG6002/Flucytosine in human patients. Taken these data all together, TG6002/Flucytosine appears as a very promising therapeutic strategy in glioblastoma patients that merits consideration for early phase clinical trial.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03294486 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Assistance Publique - Hôpitaux de Paris |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Ahmed IDBAIH, MD |
Principal Investigator Affiliation | Assistance Publique - Hôpitaux de Paris |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Unknown status |
Countries | France |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Glioblastoma, Brain Cancer |
Contact a Trial Team
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