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

Who is this study for? Patients with Medulloblastoma
What treatments are being studied? Apatinib Combined With Temozolomide and Etoposide Capsules
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 21
Healthy Volunteers: t
View:

• 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 14 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:

‣ 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 ≥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.

‣ 12\. 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.

• 14\. Patients voluntarily provide 25-30 slices of tumor tissue after the last biopsy or surgery.

• 15\. The patient has normal swallowing function and can swallow capsules. 16. The patient voluntarily joined the study and signed an informed consent form (ICF).

• 17\. Those who are expected to have good compliance can follow up the efficacy and adverse reactions as required by the plan.

Locations
Other Locations
China
Beijing Sanbo Brain Hospital
RECRUITING
Beijing
Contact Information
Primary
Jun-ping Zhang
doczhjp@hotmail.com
86+010-62856783
Time Frame
Start Date: 2020-10-28
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 44
Treatments
Experimental: Test group
Sponsors
Leads: Beijing Sanbo Brain Hospital

This content was sourced from clinicaltrials.gov