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New treatment option for Recurrent Medulloblastoma
Official title Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
ClinicalTrials.gov ID: NCT04501718
What this study is testing
What is Apatinib Combined With Temozolomide and Etoposide Capsules?
Apatinib Combined With Temozolomide and Etoposide Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent medulloblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 21. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Patients with other malignant tumors, unless they have survived without progression for 5 years and the researcher believes that the risk of...
- People with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤140 mmHg /...
- Suffering from severe cardiovascular disease; T wave inverted or high tip of ECG, ST segment specific changes.
See the full eligibility 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...
- 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...
- 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...
- 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: a. 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.