Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Cure&Sure Biotech Co., LTD|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|zhixian Gao, Doctor|
|Principal Investigator Affiliation||Beijing Tiantan Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Glioma of Brain|
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Overall Goals:
Experimental: gp96 group
Patients receive standard treatment with radiation and temozolomide after surgery. Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy. ( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. ) The first adjunctive temozolomide startes on the day of the fifth gp96 injection. (150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)
Active Comparator: control group
Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
Biological: - gp96
25 mcg IH
Drug: - Temozolomide
temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).
Radiation: - radiotherapy
Stupp regimen of radiotherapy
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.