Glioblastoma multiforme
Conditions
Interventions
single arm:Temozolomide
Sponsors
The First Hospital of Jilin Unversity
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with glioblastoma diagnosed by histopathology and/or cytology and imaging, and those who could benefit from the trial judged by the investigators 2. between 18 and 65 ,men or women 3. Karnofsky's Index ,more than 60 points 4. Expected survival is longer than 3 months; 5. Absolute neutrophil count (ANC) >= 1.5 x 10^9/ L, platelet count (PLT) >= 100 x 10^9/ L, hemoglobin (HB) >= 90g / L; 6. Alanine aminotransferase (ALT) <= 3ULN, aspartic acid aminotransferase (AST) <= 3ULN, total bilirubin (TBIL) <= 1.5ULN, serum creatinine (Cr) <= 1.5ULN; 7. Female subjects should be eligible for undergone surgical sterilization, postmenopause, or have no pregnancy plan within 6 months from the date of screening to the last administration of the study drug and voluntarily adopted effective contraceptive measures (see Appendix 5 for specific contraceptive measures); Male subjects should be eligible for sterilization or voluntary effective contraception within 6 months from the date of screening to the last dose of the study drug; 8. Sign the informed consent before the test, and fully understand the test content, process and possible adverse reactions; and be able to complete the study in accordance with the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1. Clinically has a significant history of allergies, especially those who are allergic or intolerant to nitrosourea alkylating agents (previously used nitrosourea alkylating agents with severe vomiting or severe adverse reactions); 2. Uncontrollable hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 100mmHg after active antihypertensive treatment) and poor blood glucose control (venous blood glucose = 22.2mmol / L); 3. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, Treponema pallidum antibody test results are positive; 4. Participate in any drug clinical trial within the past 3 months; 5. Any drug (including valproic acid) that has an effect on temozolomide clearance within 7 days before the test; 6. Those who have received chemotherapy with cytotoxic drugs within 28 days before treatment; 7. Patients with epilepsy that cannot be controlled by drugs within three months before enrollment; 8. Donated blood or blood loss equal to or more than 400 mL in the three months before the test, or intended to donate blood or blood components during the test or within three months after the end of the test; 9. Pre-test blood pregnancy test results of women during pregnancy, lactation or childbearing age are positive; 10. Patients who cannot tolerate venipuncture and blood collection and who are not suitable for opening intravenous infusion channels; 11. There is no guarantee that smoking will be banned from 48 hours before administration until the last blood collection; 12. Acute disease occurred during the pre-research screening phase or prior to study medication; 13. The investigator judges the subjects who are not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;QoL;security; | — |
Countries
China
Contacts
Public ContactYunqian Li
The First Hospital of Jilin University
Outcome results
None listed