Recurrent high-grade glioma (CNSWHO 34)
Conditions
Interventions
Test group:Teniposide combined with cisplatin or carboplatin
Sponsors
Beijing Tiantan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria : 1.Age = 18 years old, gender is not limited. 2.Recurrent high-grade glioma subjects confirmed by histopathology or cytology and treated with standard treatment such as surgery, radiotherapy and / or chemotherapy ( according to the 2021 WHO classification of central nervous system tumors, and CNSWHO grade 3 and 4, confirmed by imaging evaluation as progress or recurrence ). 3.According to the RANO standard, there is at least one assessable lesion. 4.The toxicity of previous anti-tumor therapy must be restored to CTCAE V5.0 grade 1 or below ( except for alopecia ). 5.If corticosteroids are used, the dose must be stable for at least 3 days before determining baseline imaging. ( The total daily dose of dexamethasone = 5mg is considered to be stable, and other corticosteroids are converted according to the equivalent dose of dexamethasone ). 6.Predicted survival time = 3 months. 7.Karnofsky performance status ( KPS ) baseline score = 70. 8.Laboratory examination must meet the following standards : ? Absolute neutrophil count ( ANC ) = 1.5 × 109 / L ? Platelet count ( PLT ) = 100 × 109 / L ? Hemoglobin ( Hb ) = 90g / L ? Total bilirubin ( TBIL ) = 1.5 × ULN. ? Aspartate aminotransferase ( AST ) = 2.5 × ULN. ? Alanine aminotransferase ( ALT ) = 2.5 × ULN. ? Creatinine clearance rate = 60mL / min ( calculated according to the Cockcroft-Gault formula ) 9.Females and men with fertility must agree to use appropriate contraceptive methods ( hormonal or barrier methods or abstinence ) during the study period and within 3 months after the last administration ; the blood pregnancy test of the female subjects of childbearing age within 7 days before administration must be negative. 10. Understand and be willing to sign written informed consent and be able to follow research protocols for treatment, visits and other research procedures.
Exclusion criteria
Exclusion criteria: Those who meet one of the following conditions shall not be selected as subjects : 1.The interval from the completion of radiotherapy to the first administration of this study was less than 4 weeks. 2.The interval between the last administration of anti-tumor therapy-related drugs and the first administration in this study was less than 5 half-lives ; ? cytotoxic drugs less than 4 weeks ( temozolomide less than 23 days, nitrosourea less than 6 weeks ) ; ? antibody therapy less than 6 weeks ; ? drug withdrawal in clinical trials was less than 4 weeks. 3. Study patients received systemic immunosuppressive therapy within 2 weeks before the start of treatment ( including but not limited to daily prednisone dose > 30mg, or the same amount of corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF-aantagonists ). 4. Major surgery was performed within 4 weeks before the first administration ; bone marrow biopsy, open biopsy and intracranial biopsy were performed within 7 days before screening. 5. Patients who cannot accept enhanced MRI examination. 6. People who need to receive live virus vaccine during administration. 7. Patients with previous or concurrent other malignant tumors, except for skin squamous cell carcinoma, skin basal cell carcinoma, cervical carcinoma in situ, thyroid cancer or breast cancer that have been cured for more than 5 years. 8. Severe complications and / or basic diseases, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal insufficiency, poor glycemic control of diabetes ( fasting blood glucose is still = 10.0mmol / L under the standard hypoglycemic regimen ). 9. Suffering from uncontrolled infection. 10. Poor control of hypertension ( systolic blood pressure = 160mmHg and / or diastolic blood pressure = 100mmHg under standard antihypertensive regimen ). 11. Congestive heart failure with New York Heart Association ( NYHA ) class 2 or above ( including class 2 ), left ventricular ejection fraction ( LVEF ) less than 50 %. To study the history of acute myocardial infarction, unstable angina pectoris, or stroke within 6 months before the start of treatment. 12. Cognitive dysfunction, history of mental illness, other uncontrolled concomitant diseases, alcohol dependence, hormone dependence or drug abuse. 13. Have a history of immunodeficiency, including : HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation. 14. HBsAg or HBcAb positive, and peripheral blood HBV DNA titer detection = 200IU / mL or = 1000copies / mL or beyond the upper limit of the normal value of the research center ; hCV antibody detection was positive, and HCV RNA detection exceeded the upper limit of the normal value of the research center ; treponema pallidum antibody positive. 15. Pregnant or lactating women. 16. Previous history of severe allergies, or allergies to any component of the test drug ( teniposide, polyoxyethylene castor oil, dimethylacetamide, anhydrous ethanol, benzyl alcohol and maleic acid ), or cisplatin / carboplatin. 17. The researchers believe that there are other factors that are not suitable for the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor evaluation;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate; ORR;Disease Control Rate; DCR;progression-free survival; PFS;Duration of Overall Response,DOR); | — |
Countries
CHINA
Contacts
Public ContactWENBIN LI
Bejing Tiantan Hospital, Capital Medical University
Outcome results
None listed