central nervous system germ cell tumors
Conditions
Interventions
Experimental group:Teniposide combined with cisplatin administration: teniposide 300mg/m2, administered continuously for 3 to 5 days, with 500ml of normal saline added each time for intravenous drip.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
3 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 3 to 80 years old, gender not limited; 2. There must be at least one measurable lesion defined by the RANO standard; 3. Initially, it has been clearly diagnosed as a central malignant germ cell tumor; 4. Expected survival period >=6 months; 5. Absolute neutrophil count >=1.0×10^9/L; 6. Platelet count >=100.0×10^9/L (excluding platelet transfusion); 7. Total bilirubin =70mL/min/1.73m2 or normal serum creatinine (Cr); 10. Parents/guardians of child or adolescent subjects who are willing and able to read, understand and sign written informed consent, and who have the ability to understand, agree to and sign the research informed consent form and the applicable child consent form before initiating any program-related procedures; 11. Fertile women and men must agree to use appropriate contraceptive methods (hormone or barrier methods or abstinence) during the study period and for three months after the last administration. The pregnancy test of female subjects of childbearing age within 7 days before administration must be negative; 12. Receive intravenous treatment with tinipposide and be willing to cooperate with at least one determination of the blood and saliva concentrations of tinipposide.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any other anti-cancer trial treatment; 2. Those with a history of severe allergies in the past, or allergic to any component of this investigatory drug (teniposide, polyoxyethylene castor oil, dimethylacetamide, anhydrous ethanol, benzyl alcohol and maleic acid), or cisplatin; 3. Those with previous or concurrent active cardiovascular diseases of clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, and arrhythmia; 4. Patients with contraindications to MRI; 5. Those who need to receive live virus vaccines during the administration period; 6. Severe complications and/or underlying diseases, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary interstitial fibrosis, renal insufficiency, and diabetes with poor blood glucose control (fasting blood glucose still >=10.0mmol/L under the standard hypoglycemic protocol), etc; 7.Those with poorly controlled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg under the standard antihypertensive protocol); 8. Uncontrolled active systemic bacterial, viral or fungal infections; 9. Patients infected with HIV or syphilis; 10. Patients who have received organ transplants in the past; 11. Pregnant or lactating women; 12.Those who are considered by the researchers to have other factors that make them unsuitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Progression-free survival rates at 6 months and 12 months;Time to Progression;Disease control rate;One-year survival rate;Quality of Life Score;Toxic and side effect;The relationship between blood drug concentration, cerebrospinal fluid concentration and therapeutic effect;Neurological score; | — |
Countries
China
Contacts
Public ContactChengcheng Guo
Sun Yat-sen University Cancer Center
Outcome results
None listed