Glioma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (including 18 and 65 years old), male and female subjects; 2. Weight 50 kg, or body mass index (BMI) generally within the scope of the 18-26, including boundary value, body mass index (BMI) = weight (kg)/height (m) 2, the surface area of 1.30-1.30 m2; 3. The imaging and pathological diagnosis of pleomorphic variant astrocytoma patients or already between patients with glioblastoma; 4. Expected lifetime is more than three months; 5. Have to have surgery or not surgery (or reject) selecting patients with chemotherapy 6. No serious heart disease, ultrasonic electrocardiogram (ecg) to evaluate the left ventricular ejection fraction >45%, no serious arrhythmia, uncontrolled hypertension without drugs, without serious liver and kidney disorders; 7. Have plenty of bone marrow hematopoietic function, absolute neutrophil count acuity 1.5* 10^9/L, the platelet count 100*10^9/L, or hemoglobin >90 g/L; 8. Karnofsky functional status score (KPS score) >=60 points; 9. From previous cytotoxic drugs chemotherapy to interval >=4 weeks, it is not merged steroid hormone treatment; 10. There is no known history of allergies to drugs and biological agents, there is no history of drug abuse; 11. to take effective contraceptive measures within six months, there is no family planning; 12. Experiment former have detailed understanding of nature, significance, may benefit, might inconvenience and potential danger, and voluntary participation in the clinical trials, understand the research procedure and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Are the central nervous system, cardiovascular system, liver and kidney function is not complete, blood system, or any other that may affect the results of the study of diseases and physiological conditions; 2. Pregnancy or breast-feeding women, did not take effective contraceptive measures, the subjects or their spouses have fertility planners within six months; 3. Allergic to nitroso urea class alkylating agent; 4. has a history of allergies to other drugs and biological agents, or other allergies; 5. Major depression, bipolar disorder and schizophrenia patients with mental disorders, a potential suicide attempt or mental mood disorder patients; 6. In active have serious systemic diseases and infectious diseases; 7. Has been combined with serious heart, liver, kidney and hematopoietic system, severe primary disease; 8. drugs cannot control patients with grand mal; 9. Unable to swallow or always accept the urea nitrate class alkylating agent patients with severe vomiting; 10. As subjects in drug clinical trials within three months, or three months had blood donors, or within 4 weeks before test had a transfusion; 11. Known HIV, HBV, HCV infected with the virus and treponema pallidum; 12. researchers think that has any unfavorable factors to participate in the test of volunteers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse;Respiration;Blood Pressure;Temperature;ECG; | — |
Countries
China