- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04842526
Efficacy and Safety of Anlotinib, Irinotecan and Temozolomide in the Treatment of Refractory or Recurrent Neuroblastoma in Children: an Open, Single Arm, Single Center, Phase II Clinical Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent was signed before admission;
- Under 21 years old, both male and female;
- Patients with distant metastasis or locally advanced neuroblastoma judged by the researchers to be unsuitable for surgical treatment;
- According to RECIST v1.1, at least one measurable lesion was judged by CT or MRI;
- Patients who have used at least one chemotherapy regimen (including anthracycline) for treatment and are evaluated as disease progression or intolerable according to RECIST 1.1;
- PS score: 0-1 (for amputees, it can be relaxed to 2); the expected survival time is more than 12 weeks;
- At least 2 weeks after the last biotherapy and 3 weeks after the last chemotherapy;
- All acute toxicity reactions caused by previous anti-tumor therapy or surgery were alleviated to 0-1 level before the screening period (according to NCI CTCAE 5.0) or to the level specified by the inclusion / exclusion criteria (except for the toxicity of alopecia, etc., which was considered by the researchers to have no safety risk to the subjects).
Adequate organ and bone marrow functions are defined as follows:
routine blood test
Neutrophil count (ANC) ≥ 1000 / mm3 (1.0 × 109 / L);
Platelet count (PLT) ≥ 70000 / mm3 (70 × 109 / L);
Hemoglobin (HB) ≥ 7.5 g / dl (75 g / L);
Blood biochemistry
Serum creatinine (CR) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance rate (cockroft Gault)
Total bilirubin (TBIL) ≤ 1.5 × ULN;
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 × ULN, liver metastasis subjects should be ≤ 5 × ULN;
Coagulation function
International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin
(APTT)≤1.5×ULN;
urinalysis
Urinary protein < 2 +; if urinary protein ≥ 2 +, 24-hour urinary protein quantitative display protein must be ≤ 1g;
Cardiac function
Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%)
- All women of childbearing age should be given adequate contraceptive treatment before and after 7 weeks of pregnancy.
- The subjects voluntarily or their legal guardians agreed to join the study, with good compliance and follow-up of safety and survival.
Exclusion Criteria:
Received the following treatment within 3 weeks before treatment:
Radiotherapy, surgery, chemotherapy and molecular targeted therapy for tumors;
Other clinical research drugs;
Live attenuated vaccine.
- Patients who had received anti angiogenic targeted drugs in the past 3 months, such as apatinib, pazoparib, sunitinib, sorafenib, bevacizumab, imatinib, clotriminib, famitinib, anlotinib, repaglinide, endostatin, etc.
- Patients who have previously received irinotecan or combined with temozolomide for progression.
- Surgery and / or radiotherapy for solid tumors were planned during the study period (regardless of < 5% of bone marrow areas).
- Long term unhealed wounds, ulcers or fractures, major surgery 28 days before enrollment or minor surgery 7 days before enrollment, known bleeding tendency, history of thrombosis 3 months before enrollment, cerebrovascular events, abdominal fistula, gastrointestinal perforation, abdominal abscess 6 months before enrollment, known brain metastasis.
- Severe infection (e.g. intravenous antibiotics, antifungal or antiviral drugs) occurred within 1 week before treatment, or fever of unknown origin > 38.5 ° C occurred during screening / before the first administration.
- Hypertension could not be well controlled by antihypertensive drugs (infants > 100 / 60mmhg, preschool children (< 6 years old) > 110 / 70mmhg, school-age children (6-12 years old) > 120 / 80mmHg, adolescence and adults (> 18 years old) > 140 / 90mmHg).
- There were significant clinical bleeding symptoms or clear bleeding tendency within 3 months before treatment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above, vasculitis, etc.; or arteriovenous thrombosis events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism Long term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥ 300 mg / day or clopidogrel ≥ 75 mg / day) is needed.
- There were active heart diseases, including myocardial infarction, severe / unstable angina pectoris, etc. within 6 months before treatment. The left ventricular ejection fraction (LVEF) was less than 50% and the arrhythmias were poorly controlled (including QTCF interval > 450 ms in male and > 470 MS in female).
- Any other malignant tumor was diagnosed within 3 years before treatment.
- Known to be allergic to the study drug or any of its excipients.
- Human immunodeficiency virus (HIV) infection, active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method).
- The patients with huge tumor, easy to burst and bleeding, tumor regression, easy to lead to bleeding and other high-risk patients.
- According to the judgment of the researcher, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, neurological or mental diseases, etc.) or any other conditions that seriously endanger the safety of the subject, may confuse the results of the study, or affect the completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib and irinotecan combined with temozolomide
|
Anlotinib, 7mg/m2, PO, was given for 14 days and stopped for 7 days; Irinotecan, 50mg/m2, D1-5, IV; Temozolomide, 100mg/m2, d1-5, PO; Three weeks is a cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: up to six months
|
Randomization began until the first tumor progression or time of death
|
up to six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Recurrence
- Neuroblastoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Temozolomide
- Irinotecan
Other Study ID Numbers
- Qiang Zhao1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory or Recurrent Neuroblastoma in Children
-
University Hospital, Strasbourg, FranceGustave Roussy, Cancer Campus, Grand ParisCompletedRefractory Solid Tumors in ChildrenFrance
-
Children's Hospital Los AngelesCompleted
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Neuroblastoma | Refractory NeuroblastomaUnited States, Canada
-
St. Jude Children's Research HospitalPfizer; IpsenRecruitingRefractory Malignant Solid Neoplasm | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Solid Neoplasm | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Recurrent Peripheral Primitive Neuroectodermal Tumor | Recurrent Rhabdoid Tumor | Recurrent... and other conditionsUnited States, Canada
-
National Cancer Institute (NCI)SuspendedRecurrent Neuroblastoma | Recurrent Osteosarcoma | Refractory Neuroblastoma | Refractory OsteosarcomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingRecurrent Neuroblastoma | Refractory Neuroblastoma | High Risk NeuroblastomaUnited States, Canada, Puerto Rico, Australia, New Zealand
-
National Cancer Institute (NCI)Children's Oncology GroupActive, not recruitingRefractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Glioma | Recurrent Malignant Solid Neoplasm | Recurrent Medulloblastoma | Recurrent Neuroblastoma and other conditionsUnited States, Puerto Rico, Australia
-
National Cancer Institute (NCI)Children's Oncology GroupActive, not recruitingRefractory Lymphoma | Refractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Histiocytic and Dendritic Cell Neoplasm | Recurrent Langerhans Cell Histiocytosis | Recurrent Lymphoma | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant... and other conditionsUnited States, Puerto Rico, Australia
-
Children's Oncology GroupNational Cancer Institute (NCI); PfizerCompletedRefractory Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Recurrent Neuroblastoma | Refractory Neuroblastoma | Refractory Anaplastic Large Cell Lymphoma | Recurrent Childhood Anaplastic Large Cell LymphomaUnited States, Canada
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Childhood Ependymoma | Advanced Malignant Solid Neoplasm | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Glioma | Recurrent Medulloblastoma | Recurrent Neuroblastoma | Recurrent Non-Hodgkin... and other conditionsUnited States, Puerto Rico
Clinical Trials on Anlotinib and irinotecan combined with temozolomide
-
Yonggao MouThe First Affiliated Hospital of Nanchang UniversityRecruiting
-
Tang-Du HospitalNot yet recruiting
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Xijing HospitalNot yet recruiting
-
Shandong Cancer Hospital and InstituteTerminatedNon-small Cell Lung CancerChina
-
The First Affiliated Hospital of Zhengzhou UniversityRecruitingNon-small Cell Lung CancerChina
-
First People's Hospital of HangzhouRecruitingRelapsed Small Cell Lung Cancer | AnlotinibChina
-
Cancer Institute and Hospital, Chinese Academy...UnknownAdenocarcinoma | NSCLC | Squamous Cell Carcinoma
-
Kunming Medical UniversityRecruitingNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorChina
-
Shanghai Chest HospitalRecruitingNon-small Cell Lung Cancer | Minimal Residual Disease | Immunotherapy | Anti-angiogenesisChina