Status:
UNKNOWN
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Duke University
Conditions:
High Grade Glioma
Glioblastoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after r...
Detailed Description
High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. ...
Eligibility Criteria
Inclusion
- Histopathologically confirmed glioma
- Age18-65
- Participants had undergone maximal surgical resection
- Amount of dexamethasone was not more than 2mg/ days
- Ability and willingness to sign informed consent
- Karnofsky Performance Score of 70 or more
- Normal liver and kidney function
- Not accepted other treatment plan during the immunotherapy
Exclusion
- Not conforming to the standard
- Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
- Received other drugs for glioma therapy 60days before participated
- Allergy to immune adjuvant
- Nervous system disease and diffuse leptomeningeal disease
- Amount of dexamethasone was more than 2mg/days during the immunotherapy
- Pregnant or lactation
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03392545
Start Date
April 1 2018
End Date
June 1 2020
Last Update
July 11 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050