Glioblastoma
Conditions
Brief summary
This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.
Detailed description
Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled. Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.
Interventions
DEVICEAVATAMED
tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response
Sponsors
Doo-Sik Kong
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. written informed consent 2. histologically confirmed glioblastoma patients who will take TMZ treatment 3. KPS \>70 4. adequte end-organ function 5. prior major surgery \> 4 weeks (prior minor surgery \> 1weeks) 6. prior standard concurrent chemo-radiation therapy \> 4 weeks 7. prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks
Exclusion criteria
1. contraindication to TMZ 2. prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy) 3. uncontrolled systemic medical illness 4. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 month PFS rate | 6 month | the fraction of patients without disease progression at 6 months after the TMZ treatment |
Countries
South Korea
Contacts
Primary ContactDoo-sik Kong, MD PhD
Outcome results
None listed