Glioma
Conditions
Interventions
Group T-R:T-R
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The tumor were diagnosed withglioblastoma, anaplastic astrocytoma with histopathology and / or cytology and imaging,and others who may be treated with temozolomide solution. And the tumors subjects who can be treated with the temozolomideccording to the judgment of the researchers; 2) Aged 18 years or over (including 18 years old); 3) KPS score =50 points; 4) Expected survival is more than 3 months; 5) ANC=1.5×10^9/L; PLT=100×10^9/L; HB=90g/L 6) ALT=3ULN; AST=3ULN; TBIL=1.5ULN; Cr=1.5ULN 7) The Surgical sterilization, post-menopausal female subjects or female subjects whohas no pregnancy plan within 6 months from the screening day to the last dose of the study drug as well who have taken the effective contraceptive measures (Specific contraceptive measures are shown in Appendix 5). The surgical sterilization male subjects or who have taken the effective contraceptive measures from the screening day to the last dose of the study drug (Specific contraceptive measures are shown in Appendix 5); 8) The subjects who signed the informed consent form before the trial.They can fully understand the content, process and possible side effects of the experiment, and they can completethe research according to the protocol.
Exclusion criteria
Exclusion criteria: 1. The subjects have a significant clinical history of allergy, especially those who are allergic to or intolerant of the nitrosin. (The subjects had severe vomiting or serious adverse reactions, after the use of nitrourea alkylating agents in past medical); 2. Uncontrollable hypertension (systolic BP =180 mmHg or diastolic BP =100 mmHg after active antihypertensive treatment) and poor glycemic control (venous glucose =2.7 mmol/L or =22.2 mmol/L); 3. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, Treponema pallidum antibody test results were positive; 4. Participate in any drug clinical trials in the last 3 months; 5. Any medication that affected temozolomide clearance (including valproic acid) was used within 7 days before the test; 6. Those who received cytotoxic drug chemotherapy within 28 days prior to treatment; 7. The patient who developed grand mal seizures that could not be controlled by medication within the first 3 months of enrollment; 8. Donated blood or blood loss equal to or more than 400 mL within the first three months of the trial or intended to donate blood or blood components during the trial or within three months after the trial has ended; 9. Women in pregnancy, lactation or childbearing age whose test results were positive before the test; 10. Subject can not tolerate venipuncture blood and upper limb is not suitable for people who open the venous infusion channel; 11. Subject can not guarantee smoking from the first 48 hours before administration to the last before blood collection; 12. Subject who develops an acute illness during the screening phase or before the formal test; 13. Ineligible by the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Respiration;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed