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Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children

NCT04501718•Beijing Sanbo Brain Hospital

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

2 - 21 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age 2-21 (at the time of diagnosis), no gender limit.
•2. After biopsy or surgery, the first postoperative pathological diagnosis is medulloblastoma.
•3. 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.
•4. The time interval from the last radiotherapy is ≥4 weeks.
•5. 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.
•6. The interval between the last biopsy or surgery is ≥2 weeks.
•7. KPS score ≥50 (patient\> 12 years old), or Lansky score ≥ 50 (patient ≤ 12 years old).
•8. If the patient is taking glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 1 week before the baseline MRI.
•9. The expected survival time is ≥12 weeks.
•10. 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:
+12 more criteria

Exclusion Criteria

•1. Past application of anti-tumor angiogenesis drugs;
•2. Those who are known to be allergic to any component of temozolomide, apatinib, and etoposide;
•3. 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;
•4. 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;
•5. 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);
•6. Suffering from severe cardiovascular disease; T wave inverted or high tip of ECG, ST segment specific changes.
•7. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
•8. 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;
•9. There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction;
•10. There is an infection that is difficult to control;
+4 more criteria

Locations (1)

Beijing Sanbo Brain Hospital

Beijing, China

Key Dates

Start Date

October 28, 2020

Primary Completion Date

August 31, 2025

Completion Date

August 31, 2025

Last Updated

October 15, 2024

Enrollment

ESTIMATED participants

Conditions

Recurrent Medulloblastoma

Interventions

Apatinib Combined With Temozolomide and Etoposide Capsules

DRUG

Contacts

Jun-ping Zhang

CONTACT

86+010-62856783 doczhjp@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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