neuroblastoma
Conditions
Interventions
Intervention type:DRUG
Name of intervention:APN311
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAVENOUS DRIP
Dose per administration:10
Sponsors
Yoshiyuki Takahashi, MD, PhD
Department of Developmental Pediatrics
Nagoya University Graduate School of Medicine
65 Tsurumai-cho, Showa-ku, Nagoya
466-8550, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients will be considered eligible to enter the study if they satisfy all of the following inclusion criteria: a)>= 12 months and == 30 % by Echocardiogram -no dyspnea at rest and a pulse oximetry > 94% on room air -Adequate bone marrow function as defined by ANC > 1,000/mcL, platelets >= 50,000/mcL and hemoglobin > 9.0 g/dL -Adequate liver function, as defined by an ALT or AST 60 mL/minute/1.73 m2
Exclusion criteria
Exclusion criteria: Patients are NOT eligible for this study if they meet any of the following exclusion criteria: a)Patients with hypersensitivity against one component of the investigational product or against mouse proteins b)Progressive disease with a rising tumor marker value or an increasing tumor size evaluated by MIBG scan/CT/MRI c)Previous treatment with an anti-GD2 antibody (e.g. ch14.18/SP2/0, ch14.18/CHO) d)Platelet transfusion dependency e)Significant intercurrent illnesses and/or any of the following: -Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance -Patients with significant psychiatric disabilities or uncontrolled seizure disorders -Patients with active infections or active peptic ulcer, unless these conditions are corrected or controlled -Patients with a clinically significant neurologic deficit or objective peripheral neuropathy (Grade >2) -Patients with clinically significant, symptomatic pleural effusions f)Requirement, or likely requirement, for corticosteroid or other immunosuppressive drugs g)Concurrent treatment with any non-trial anticancer therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse events, vital signs (blood pressure, pulse rate, temperature) and changes in clinical laboratory assessments -Assessment of pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pharmacokinetic parameters -Pharmacodynamic parameters -Immunogenicity (HACA) -Anti-tumor activity in patients with evaluable/measureable disease | — |
Countries
Japan
Contacts
Public ContactKatsuyoshi Kato
Nagoya University Hospital
Outcome results
None listed