Recurrent MedulloblastomaPhase 2NCT04501718
Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
A Phase 2 study testing Apatinib Combined With Temozolomide and Etoposide Capsules in people with Recurrent Medulloblastoma, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Medulloblastoma
- What is being tested?
- Apatinib Combined With Temozolomide and Etoposide Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2020to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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:
- 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:
- 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.
Who cannot join
- 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.
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- 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, fecal occult blood++ and above at baseline, intratumoral or Intracranial hemorrhage, or suffering from vasculitis, etc.;
- 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 thrombosis, and pulmonary embolism;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Sanbo Brain Hospital
Beijing
Jun-ping Zhang, 86+010-62856783, doczhjp@hotmail.com
About this study
Official title: A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
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.
Read the 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.
- Conditions
- Recurrent Medulloblastoma
- Being tested
- Apatinib Combined With Temozolomide and Etoposide Capsules
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Combined With Temozolomide and Etoposide CapsulesDrug
Apatinib mesylate tablets: Oral, 250mg, qd. Take the medicine with warm water half an hour after a meal (the daily medicine should be taken at the same time as possible).
28 days is a cycle, and the medication is administered until the disease progresses (PD), intolerable toxicity occurs or the patient withdraws informed consent. The longest period does not exceed 12 cycles. The treatment after 12 cycles is determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: Apatinib Combined With Temozolomide and Etoposide Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: up to 4 years
Progression-free survival (PFS)
Measured: up to 4 years
Overall survival (OS)
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start28 Oct 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MedulloblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junping Zhang, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501718
- Sponsor's protocol ID
- OBU-BJ-MB-II-001
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
- ClinicalTrials.gov ID
- NCT04501718
- Acronym / sponsor ID
- OBU-BJ-MB-II-001
- Conditions
- Recurrent Medulloblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Apatinib Combined With Temozolomide and Etoposide Capsules |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (14 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib Combined With Temozolomide and Etoposide CapsulesApatinib mesylate tablets: Oral, 250mg, qd. Take the medicine with warm water half an hour after a meal (the daily medicine should be taken at the same time as possible). 28 days is a cycle, and the medication is administered until the disease progresses (PD), intolerable toxicity occurs or the patient withdraws informed consent. The longest period does not exceed 12 cycles. The treatment after 12 cycles is determined by the investigator. | Drug | Test group |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 4 years
Progression-free survival (PFS)
Time frame: up to 4 years
Overall survival (OS)
Time frame: up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib Combined With Temozolomide and Etoposide Capsules in people with Recurrent Medulloblastoma, run by Beijing Sanbo Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-ping Zhang (86+010-62856783, doczhjp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.