Actively Recruiting
A Single Arm Clinical Phase II Study of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining apatinib with temozolomide and oral etoposide for treating children with recurrent medulloblastoma, a type of brain tumor. This phase 2 clinical study is conducted following Good Clinical Practice principles at Beijing Sanbo Brain Hospital. The goal is to observe how well this treatment works and assess its safety in children whose tumors have returned. Participants receive oral apatinib mesylate tablets at a dose of 250 mg daily, taken with warm water about half an hour after a meal. Each treatment cycle lasts 28 days, continuing until the tumor progresses, unacceptable side effects occur, or the participant chooses to withdraw, with a maximum treatment duration of 12 cycles. After 12 cycles, further treatment decisions are made by the investigator. During the study, researchers will monitor tumor response and survival outcomes using imaging studies, with treatment lasting up to two years or until progression or death. They will assess objective response rate, progression-free survival, and overall survival for up to four years. Participants will undergo regular safety and effectiveness evaluations, including imaging scans and clinical assessments, to track treatment effects and side effects throughout the study period.
CONDITIONS
Brief 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 medulloblastoma diagnosis after biopsy or surgery
- Tumor recurrence confirmed by MRI or pathological diagnosis
- At least 4 weeks since last radiotherapy
- At least 4 weeks since last chemotherapy with full recovery; 6 weeks if prior nitrosourea chemotherapy
- At least 2 weeks since last biopsy or surgery
- KPS score ≥50 for patients older than 12 years, Lansky score ≥50 for patients 12 years or younger
- Stable or decreased glucocorticoid dosage for at least 1 week before baseline MRI
- Expected survival time of at least 12 weeks
- Normal major organ functions and no serious blood, heart, lung, liver, kidney dysfunction or immune deficiency
- Laboratory tests meeting specified blood count, biochemistry, urine, ECG, and coagulation criteria
- Negative pregnancy test for females of childbearing age and agreement to use contraception during and after treatment
- Willingness to provide tumor tissue samples
- Ability to swallow capsules
- Signed informed consent and expected good compliance
You will not qualify if you...
- Previous use of anti-tumor angiogenesis drugs
- Known allergy to temozolomide, apatinib, or etoposide components
- Use of liver enzyme-inducing antiepileptic drugs unless replaced at least 2 weeks before enrollment
- Presence of other malignant tumors unless stable for 5 years or carcinoma in situ
- Uncontrolled hypertension despite medication
- Severe cardiovascular disease or abnormal ECG changes
- Significant proteinuria or abnormal coagulation
- Conditions affecting oral drug absorption like severe nausea or intestinal obstruction
- Uncontrollable infection
- Recent significant bleeding or bleeding tendency within 3 months
- Recent arterial or venous thrombosis events within 6 months
- Pregnancy or breastfeeding, or unwillingness to use effective contraception
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 12 cycles of 28 days each
Participants receive Apatinib combined with Temozolomide and Etoposide capsules. The medication is taken orally daily in 28-day cycles until disease progression, intolerable toxicity, withdrawal, or up to 12 cycles.
Visits occur regularly during each 28-day treatment cycle
Trial Site Locations
Total: 1 location
1
Beijing Sanbo Brain Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jun-ping Zhang
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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