Apatinib Combined With Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    44
  • sponsor
    Beijing Sanbo Brain Hospital
Updated on 24 March 2022
Accepts healthy volunteers

Summary

This study is a prospective single-center clinical study, which aims to observe and evaluate the efficacy and safety of apatinib combined with temozolomide and oral etoposide in the treatment of recurrent medulloblastoma in children.

Description

This research plan is implemented in accordance with GCP principles in Sanbo Brain Hospital of Capital Medical University.

Subjects are screened into the group. If the following conditions do not occur (the subject withdraws the informed consent, the drug side effects are intolerable, the investigator thinks it is not suitable for further testing, etc.), the expected research treatment for each subject It will continue until tumor progression or death confirmed by imaging studies, but not more than 2 years. Observe the effectiveness index and safety index during the test.

Details
Condition Recurrent Medulloblastoma
Treatment Apatinib Combined With Temozolomide and Etoposide Capsules
Clinical Study IdentifierNCT04501718
SponsorBeijing Sanbo Brain Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 2-21 (at the time of diagnosis), no gender limit
After biopsy or surgery, the first postoperative pathological diagnosis is medulloblastoma
The recurrence of the tumor is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice spacing 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is medulloblastoma
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. If you receive nitrosourea chemotherapeutics before enrollment, the interval between enrollment and the last chemotherapy is ≥6 weeks
The interval between the last biopsy or surgery is ≥2 weeks
KPS score ≥50 (patient> 12 years old), or Lansky score ≥ 50 (patient ≤ 12 years old)
If the patient is taking glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 1 week 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
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
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; 11. The ECG shows that the heart rate is in the normal range (55-100 beats/min), the QT interval is normal or slightly prolonged (QTc<480ms), the T wave is normal or low, and the ST segment is normal or non-specific changes
The coagulation function is normal, without active bleeding and thrombosis
International standardized ratio INR≤1.5×ULN
Partial thromboplastin time APTT≤1.5×ULN
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; male patients of childbearing age should agree to During the observation period and within 8 weeks after the last administration, use appropriate methods of contraception
Patients voluntarily provide 25-30 slices of tumor tissue after the last biopsy or surgery
The patient has normal swallowing function and can swallow capsules. 16. The patient voluntarily joined the study and signed an informed consent form (ICF)
Those who are expected to have good compliance can follow up the efficacy and adverse reactions as required by the plan

Exclusion Criteria

Past application of anti-tumor angiogenesis drugs
Those who are known to be allergic to any component of temozolomide, apatinib, and etoposide
Are using antiepileptic drugs that induce liver drug enzymes, unless they have been replaced with antiepileptic drugs that are non-hepatic drug enzymes at least 2 weeks away from enrollment
Patients with other malignant tumors, unless they have survived without progression for 5 years and the researcher believes that the risk of recurrence is low or patients with carcinoma in situ
People 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)
Suffering from severe cardiovascular disease; T wave inverted or high tip of ECG, ST segment specific changes
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
Have had significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, fecal occult blood++ and above at baseline, intratumoral or Intracranial hemorrhage, or suffering from 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
Other situations that the researcher thinks are not suitable for inclusion
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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