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

NCT04501705 | Recruiting

• 1 other identifier: OBU-BJ-CM-Ⅱ-008
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Atypical/malignant Meningioma

Outcome Measures

Primary Outcomes (1)

• PFS-6 %

  6-month progression-free survival

  6-month progression-free survival

Secondary Outcomes (2)

• ORR

  up to 5 years

• OS

  up to 5 years

Study Arms (1)

test group

EXPERIMENTAL

Drug: Apatinib Mesylate

Interventions

Apatinib Mesylate DRUG

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.

test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old (at the time of enrollment), regardless of gender.
• The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery.
• 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.
• 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
• The time interval from the last radiotherapy is ≥4 weeks.
• The time interval from the last chemotherapy is ≥4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment.
• The interval between the last biopsy or surgery is ≥2 weeks.
• KPS score ≥50 points.
• If the patient is on glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 2 weeks before the baseline MRI.
• The expected survival time is ≥12 weeks.
• 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):
• HGB≥100g/L;
• WBC≥3.0×109/L; NEUT≥1.5×109/L;
• PLT ≥100×109/L; (2) The biochemical inspection shall meet the following standards:

You may not qualify if:

• Past application of anti-tumor angiogenesis drugs;
• Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes;
• People who are known to be allergic to any component of apatinib mesylate;
• 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;
• 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;
• 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);
• Patients with coronary heart disease ≥2 grade, arrhythmia (including QTc prolongation in men\>450 ms, women\>470 ms) and cardiac insufficiency;
• Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
• 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;
• There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction;
• There is an infection that is difficult to control;
• 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.;
• 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;
• Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Sanbo Brain Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Central Study Contacts

Jun-ping Zhang, Chief Physician

CONTACT

86-010-62856783; doczhjp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: August 18, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)