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New treatment option for Neuroblastoma
Official title Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
ClinicalTrials.gov ID: NCT05027386
What this study is testing
What is Apatinib, Irinotecan, Temozolomide?
Apatinib, Irinotecan, Temozolomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for neuroblastoma.
Also referred to as Irinotecan, temozolomide.
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
- The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor.
- 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 5 to 18
You may be able to join if
- 5years ≤ age ≤18 years old, regardless of gender;;
- ECOG performance status (PS) score: 0～1;
- The expected survival time is more than 12 weeks;
- Children with neuroblastoma confirmed by histopathology;
- Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after...
You likely can't join if
- Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before enrollment and have stable symptoms can be...
- Imaging (CT or MRI) shows that the tumor focus is ≤ 5 mm from large blood vessels, or there is a tumor that invades local large blood vessels;
- Patients with hypertension who are using two or more antihypertensive drugs in combination therapy;
- Patients who suffer from the following cardiovascular diseases: Myocardial ischemia or myocardial infarction above grade II, poorly controlled...
- Patients with a history of interstitial pulmonary disease or who also suffer from the interstitial pulmonary disease;
- Abnormal coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds or APTT\>1.5 ULN), have a bleeding tendency or are receiving...
See the full eligibility criteria
Who can join
- 5years ≤ age ≤18 years old, regardless of gender;;
- ECOG performance status (PS) score: 0～1;
- The expected survival time is more than 12 weeks;
- Children with neuroblastoma confirmed by histopathology;
- Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);
- With measurable lesions (according to the RECIST 1.1 standard, the CT scan of tumor lesions has a long diameter ≥10mm, and the CT scan of lymph node lesions has a short diameter ≥15mm. The measurable lesions have not...
- The patients must recover from the acute toxic effects of all previous anticancer chemotherapy fully;
- Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (If nitrosourea was used in the early stage, the interval time is 42 days);
- Experimental drugs or anti-cancer therapies other than chemotherapy: It is not allowed to use other experimental drugs within 28 days before the planned start of use, and it is necessary to fully recover from the...
- Hematopoietic growth factors: at least 14 days after the last administration of long-acting growth factors or 3 days after the last administration of short-acting growth factors;
- 11\. Immunotherapy: At least 42 days after completing any type of immunotherapy (except steroids), such as immune checkpoint inhibitors and tumor vaccines;
- 12\. X-ray therapy (XRT): at least 14 days after local palliative XRT (small-scale mouth); if it is another substantial bone marrow (BM) irradiation, including pre-radio-iodinated metaiodobenformin (131I-MIBG)...
- Stem cell infusion without total body irradiation (TBI): there is no evidence of active graft-versus-host disease, at least 56 days after transplantation or stem cell infusion;
- Laboratory inspections during the screening period should meet the following conditions: The absolute value of neutrophils (ANC) ≥1.5×109/L (if the bone marrow is invaded, then ANC≥1.0×109/L) Platelet (PLT) ≥75×109/L...
- During the study period, patients should be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits;
- Parents/guardians of a child or young patients have the ability to understand, agree, and sign the research informed consent form (ICF) and applicable child consent form before initiating any program related procedures...
What rules you out
- Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before enrollment and have stable symptoms can be enrolled, but they need to be evaluated by cranial MRI, CT, or...
- Imaging (CT or MRI) shows that the tumor focus is ≤ 5 mm from large blood vessels, or there is a tumor that invades local large blood vessels;
- Patients with hypertension who are using two or more antihypertensive drugs in combination therapy;
- Patients who suffer from the following cardiovascular diseases: Myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for...
- Patients with a history of interstitial pulmonary disease or who also suffer from the interstitial pulmonary disease;
- Abnormal coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds or APTT\>1.5 ULN), have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- The daily volume of hemoptysis reached two teaspoons or more before enrollment;
- Patients who have had clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, fecal...
- Arterial/venous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein...
- Known existing hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
- Long-term unhealed wounds or fractures (pathological fractures caused by tumors are not counted);
- Patients who received major surgery or suffered severe traumatic injury, fracture, or ulcer within 4 weeks of enrollment;
- some factors significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 6 months before enrollment;
- Urine routine test showed urine protein ≥ ++, and confirmed 24-hour urine protein ≥ 1.0 g; Notes: Asymptomatic serous effusions can be included in the group, and symptomatic serous effusions have been actively treated...
- Active infections require antimicrobial treatment (for example, antibacterial drugs and antiviral drugs are required, excluding chronic hepatitis B anti-hepatitis B treatment, antifungal drug treatment);
- Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
- Participated in other anti-tumor drug clinical trials within 4 weeks before joining the group;
- Previously or concurrently suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer;
- Within 7 days before the first administration, patients used drugs or foods known to be potent inhibitors of CYP3A4, including but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, ketocon Azole...
- Within 12 days before the first administration, use drugs known to be strong inducers of CYP3A4, including but not limited to: carbamazepine, phenobarbital, phenytoin, rifabutin, and rifapar;
- Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;
- The investigator judges other situations that may affect the conduct of clinical research and the judgment of research results.
- When the virological test during the screening period shows that any of the following is met:HBsAg is positive and HBV DNA exceeds the upper limit of normal Anti-HCV positive and HCV RNA positive HIV positive.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.