Pediatric Brain Tumor Foundation
Working to eliminate the challenges of childhood brain tumors

Cure the kids! Give Now

Apatinib in the Treatment of Recurrent Atypical/Malignant Meningioma in Adults

Study Purpose

Apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18 years old (at the time of enrollment), regardless of gender. 2. The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery. 3. The tumor recurrence is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice interval 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is atypical/malignant meningioma. 4. Previous surgery and radiotherapy (including conventional radiotherapy or stereotactic radiosurgery treatment) are required. There are no restrictions on whether to receive chemotherapy or the number of times of the above treatments. 5. The time interval from the last radiotherapy is ≥4 weeks. 6. The time interval from the last chemotherapy is ≥4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment. 7. The interval between the last biopsy or surgery is ≥2 weeks. 8. KPS score ≥50 points. 9. If the patient is on glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 2 weeks before the baseline MRI. 10. The expected survival time is ≥12 weeks. 11. The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. The laboratory inspection meets the following requirements:
  • (1) Routine blood examination, which must be met (no blood transfusion within 14 days): 1.
HGB≥100g/L; 2. WBC≥3.0×109/L; NEUT≥1.5×109/L; 3. PLT ≥100×109/L;
  • (2) The biochemical inspection shall meet the following standards: a.
BIL≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.0×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
  • (3) Occult blood in stool (-); (4) Urine routine is normal, or urine protein <(++), or 24-hour urine protein <1.0 g; (5) Left ventricular ejection fraction (LVEF) ≥50%.
12. The coagulation function is normal, without active bleeding and thrombosis. 1. International standardized ratio INR≤1.5×ULN; 2. Partial thromboplastin time APTT≤1.5×ULN; 3. Prothrombin time PT≤1.5ULN. 13. Female patients of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets ; Male patients of childbearing age should agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets. 14. Patients need to provide 25-30 pieces of tumor tissue slices after the last biopsy or surgery. 15. The patient has normal swallowing function and can swallow the tablet intact. 16. The patient voluntarily joined the study and signed an informed consent form (ICF). 17. The patient is expected to have good compliance and be able to follow up the efficacy and adverse reactions as required by the protocol.

Exclusion Criteria:

1. Past application of anti-tumor angiogenesis drugs; 2. Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes; 3. People who are known to be allergic to any component of apatinib mesylate; 4. Antiepileptic drugs that induce liver enzymes are being used, unless antiepileptic drugs that have been replaced with non-hepatic enzymes are at least 2 weeks away from enrollment; 5. Patients with other malignant tumors, unless they have survived for 5 years and the investigator believes that the risk of recurrence is low or patients with carcinoma in situ; 6. Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg); 7. Patients with coronary heart disease ≥2 grade, arrhythmia (including QTc prolongation in men>450 ms, women>470 ms) and cardiac insufficiency; 8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g; 9. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5×ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction; 11. There is an infection that is difficult to control; 12. Those who had significant blood coughing up 2 months before enrollment, or had blood volume of 2.5ml or more per day; had clinically significant bleeding symptoms or had clear bleeding tendency within 3 months before enrollment, such as Gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, stool occult blood++ and above at baseline, intratumoral or intracranial hemorrhage, or vasculitis, etc.; 13. Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 14. Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures; 15. Other situations that the researcher thinks are not suitable for inclusion.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04501705
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Sanbo Brain Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Atypical/Malignant Meningioma
Additional Details

Vascular endothelial growth factor VEGF is related to the abnormal angiogenesis of meningioma and can also activate other growth factor pathways. Meningiomas are vascular tumors. Studies have shown that the expression of VEGF in atypical meningiomas is twice that of benign meningiomas, and VEGF in anaplastic meningiomas is 10 times that of benign meningiomas. Therefore, anti-angiogenesis therapy may be more effective for higher grade meningiomas. Previous clinical studies have confirmed that anti-angiogenic drugs such as bevacizumab, sunitinib and PTK 787 can slow down tumor growth and prolong progression-free survival for recurrent atypical/malignant meningioma. In summary, apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.

Arms & Interventions

Arms

Experimental: test group

Interventions

Drug: - Apatinib Mesylate

Apatinib mesylate tablets: Orally, 500 mg, once a day, with warm water for half an hour after a meal (the time of taking the medicine every day should be the same as possible). Continue to use 28 days as a cycle, medication until disease progression (PD), intolerable toxicity occurs or the patient withdraws informed consent. However, the longest period does not exceed 24 cycles, and the treatment after 24 cycles is determined by the investigator.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sanbo Brain Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Sanbo Brain Hospital

Beijing, Beijing,

Site Contact

Jun-ping Zhang, Chief Physician

doczhjp@hotmail.com

86-010-62856783