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||20 Years - 75 Years|
Inclusion Criteria:1. Newly diagnosed, histologically confirmed GBM WHO Grade IV (any wildtype or mutant or gene type, except gliosarcoma), non-resectable or partially resected or resected. 2. Age 20
- - 75 years.
Exclusion Criteria:1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. 2. Pregnancy or lactation. 3. Expected non-compliance. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social . 5. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome. 6. Subjects who had been treated with ADI-PEG 20 previously. 7. History of uncontrolled seizure disorder not related to underlying cancer. 8. Known HIV positivity, or active hepatitis B infection, or active hepatitis C infection (testing not required). 9. Allergy to pegylated compounds. 10. Allergy to E. coli drug products (such as GMCSF). 11. Allergy to TMZ or any of its components. 12. History of hypersensitivity to dacarbazine. 13. Placement of Gliadel wafer at surgery. 14. Having a co-existing condition requiring systemic treatment with either corticosteroids or immunosuppressive medication.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kuo-Chen Wei, M.D.|
|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.
|Glioblastoma Multiforme (GBM)|
Experimental: ADI-PEG 20 plus Radiotherapy and Temozolomide
ADI-PEG 20 Dose: 18 and 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Radiotherapy Dose: 60 Gy in 30 daily (Monday-Friday) fractions of 2 Gy each; to start within 5 weeks of surgery (diagnostic and/or resection) Temozolomide Dose: 75 mg/m2 daily during radiotherapy; 150-200 mg/m2 for 5 days every 4 weeks (1 cycle) x 6 cycles during maintenance period Route of Administration: oral or intravenous
Drug: - ADI-PEG20
Drug: - Temozolomide
Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.
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.