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 - 70 Years|
Inclusion Criteria:1. Specimen collection screening
- - Karnofsky performance status (KPS) ≥ 60 at assessment prior to surgery - ≥ 18 and ≤ 70 years of age - Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression occurred.
- - Contrast-enhanced MRI suspects recurrent GBM - Supratentorial tumor - Must voluntarily sign and date informed consent form for specimen acquisition and future use, for study screening, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures 2.
- - Karnofsky performance status (KPS) ≥ 60 at randomization - Submission of fresh tumor - Post-operation contrast-enhanced MRI scan must be done after surgical resection, with the intent for cyto-reduction ≥ 80% of the contrast-enhancing tumor mass - Histologically confirmed WHO grade IV glioma by pathology tissue screening - Subjects receiving bevacizumab as standard of care for given indication - Subject has adequate bone marrow, renal, and hepatic function prior to randomization as follow: 1.
- - Subjects with recurrent GBM (Grade IV) are eligible for this protocol.
- - Must voluntarily sign and date informed consent form, for study participation,
approved by an Independent Ethics Committee (IEC)/ Institutional Review Board
(IRB), prior to the initiation of any study-specific procedures
- - Multifocal GBM - Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ of breast, oral cavity or cervix) unless disease free for ≥ 2 years - Subject has used bevacizumab or immune checkpoint blockade to treat GBM - Lactating or pregnant female - Positive viral serology for HIV or syphilis at time of screening 2.
- - Subjects having a biopsy only at surgery or tumor cell insufficiency at preparation - Inability to undergo contrast-enhanced MRI scans - Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia) - Inability to stop or decrease the use of corticosteroid doses to 4 mg/day prior to randomization - Tumor progression documented according to modified RANO criteria prior to randomization (approximately 5 weeks after surgery) - Severe, active comorbidity, defined as follow: 1.
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.
|Safe Save Medical Cell Sciences & Technology Co.,Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Peng-Wei Hsu, MD|
|Principal Investigator Affiliation||Chang Gung Memorial Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Standard therapy with ADCTA vaccine (study group)
- ADCTA vaccine as study treatment Dose(s): Ten doses, including 2~4×10^7 cells for the 1st dose (double doses), and 1~2×10^7cells for the 2nd to 10th doses. Administrative route: The ADCTA vaccine will be injected in axillar or inguinal regions close to lymphnodes subcutaneously at clinic. Frequency: The primary immunization inoculation is followed by 3 vaccines bi-weekly and then 6 vaccines monthly inoculation, for a total of 10 doses. - Bevacizumab as standard therapy
Active Comparator: Standard therapy (control group)
No study treatment Bevacizumab as standard therapy
Biological: - Autologous Dendritic Cell/Tumor Antigen, ADCTA
ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.
Contact a Trial Team
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.