Actively Recruiting
Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
Led by Beijing Sanbo Brain Hospital · Updated on 2024-10-15
44
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 21 years at diagnosis, any gender
- Confirmed diagnosis of medulloblastoma by biopsy or surgery
- Tumor recurrence confirmed by MRI showing lesion diameter ≥1 cm on at least 2 slices or by pathology
- At least 4 weeks since last radiotherapy
- At least 4 weeks since last chemotherapy with full recovery from acute toxicity; 6 weeks if nitrosourea chemotherapy was used
- At least 2 weeks since last biopsy or surgery
- KPS score ≥50 for patients older than 12 years, or Lansky score ≥50 for patients 12 years or younger
- Stable or reduced glucocorticoid dose for at least 1 week before baseline MRI
- Expected survival time of at least 12 weeks
- Normal main organ function without serious blood, heart, lung, liver, kidney dysfunction or immune deficiency
- Routine blood test results meeting specific hemoglobin, white blood cell, neutrophil, and platelet levels without recent transfusion
- Biochemical tests within defined limits for bilirubin, liver enzymes, and kidney function
- Negative occult blood in stool
- Normal or acceptable urine test results with protein levels below specified thresholds
- ECG showing normal heart rate, QT interval, T wave, and ST segment
- Normal coagulation function without active bleeding or thrombosis
- Female patients of childbearing age with negative pregnancy test and agreeing to contraception; male patients agreeing to contraception
- Provision of 25-30 tumor tissue slices after last biopsy or surgery
- Ability to swallow capsules
- Voluntary informed consent signed
- Expected good compliance for follow-up of efficacy and side effects
You will not qualify if you...
- Previous use of anti-tumor angiogenesis drugs
- Known allergy to any components of temozolomide, apatinib, or etoposide
- Use of liver enzyme-inducing antiepileptic drugs unless replaced by non-enzyme-inducing drugs at least 2 weeks before enrollment
- Presence of other malignant tumors unless disease-free for 5 years or carcinoma in situ with low recurrence risk
- Uncontrolled hypertension above specified blood pressure limits despite treatment
- Severe cardiovascular disease or abnormal ECG signs such as T wave inversion or specific ST segment changes
- Urine protein levels above specified thresholds
- Abnormal coagulation or bleeding disorders, or receiving thrombolytic/anticoagulant therapy
- Conditions affecting oral drug absorption like uncontrollable nausea, vomiting, chronic diarrhea, or intestinal obstruction
- Difficult-to-control infections
- Significant bleeding within 3 months prior to enrollment or bleeding tendencies
- Arterial or venous thrombosis within 6 months prior to enrollment
- Pregnancy, breastfeeding, or unwillingness/inability to use contraception
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Sanbo Brain Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jun-ping Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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