Pediatric brain tumor
Conditions
Interventions
entrectinib at a dose of 600 mg/m2 orally once per day
Sponsors
Kurimoto Michihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Primary brain tumors with ROS1 gene fusions that are locally advanced; gene fusions are defined as those predicted to translate into a fusion protein with a functional ROS1 kinase domain, without a concomitant second oncodriver (e.g. known, activating mutations in EGFR, KRAS) as determined by a nucleic acid-based diagnostic testing method approved in Japan. 2.Patients who have no satisfactory treatment options for primary CNS tumors. 3.Performance status: PS (ECOG) 0-2 and minimum life expectancy of at least 4 weeks. 4.Age: Male or female from birth to age =14 days after whole brain XRT;>=7 days after stereotactic radiation surgery. 9.Organ function; i. ANC >= 1,000/microL; ii. Hemoglobin >= 8.0 g/dL (without transfusion within 14 days of registration) iii. Platelet count >= 75,000/microL (without transfusion) iv. Bilirubin =; 0.8mg/dl, 5-10; 1.2mg/dl and 10<=; 1.5mg/dl) vii. ECG with QTcF <= 480 msec 10. Written informed consent: A signed informed consent and/or assent for study participation will be obtained from patients, parents or caregivers. (Written informed consent should be obtained from patients more than 7 years old.).
Exclusion criteria
Exclusion criteria: 1.Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2. Active infection requiring systemic therapy. 3.Body temperature >= 38 degrees Celsius at registration. 4.Women during pregnancy, possible pregnancy or breast-feeding. 5.Continuous systemic use of immunosuppressant including steroid. 6.Uncontrolled diabetes mellitus or routine administration of insulin. 7.Congestive heart failure within 3 months or ejection fraction <= 50%. 8.Inadequately controlled hypertension. 9.Known congenital long QT syndrome. 10.Familial history of long QT syndrome. 11.Positive HBs antigen, positive HBs antibody or positive HBc antibody. 12.Positive HCV antibody. 13.Positive HIV antibody. 14.Pneumonitis, pulmonary fibrosis, or severe lung emphysema on chest CT. 15.Patients who were judged as inappropriate for entry in this study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall best response until four courses | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time, the number of adverse events | — |
Contacts
Public ContactHideki Muramatsu
Nagoya University Hospital
Outcome results
None listed