A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Doo-Sik Kong40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glioblastoma

Interventions

AVATAMEDDEVICE

tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

6 month PFS rate

the fraction of patients without disease progression at 6 months after the TMZ treatment

Time frame: 6 month

Central Contacts

Doo-sik Kong, MD PhD

CONTACT

82-2-6182-5036 doosik.kong@samsung.com

Data from ClinicalTrials.gov

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