refractory pediatric central nervous system tumors
Conditions
Interventions
NCCV Cocktail-1 is administered by subcutaneous injection for a maximum of 1 year.
Sponsors
Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven central neurological tumors and diffuse intrinsic pontine glioma diagnosed on images. 2) aged 30 or less 3) Medical history of standard therapy 4) Refractory to further treatment by the following reason. i. new lesion. ii. progression disease. iii. diffuse intrinsic pontine glioma 5) ECOG Performance Status of 0-2, or 3 due to neurological disorder or limb loss. 6) Adequate organ function. i.e. meet all criterion as follows. i. Absolute neutrophil count >= 1,000 /mm3 ii. Platelet count >= 50,000 /mm3 iii. Total bilirubin <= 1.5 mg/dL iv. AST <= 200 IU/L v. ALT <= 200 IU/L vi. serum creatinine <= 0.8 mg/dL (1 years-4 years) <= 1.2 mg/dL (5 years-9 years) <= 1.5 mg/dL (10 years-39 years) 7) Written informed consent; over 20 years old: from patient own between 16 to 19 years old: from legal acceptable representative and patient 15 years and under: from legal acceptable representative 8) HLA-A*24:02 positive. 9) In tumor cells, any of the cancer antigens of KOC1, FOXM1, or KIF20A have been confirmed by immunostaining except diffuse intrinsic pontine glioma
Exclusion criteria
Exclusion criteria: 1) Chemotherapy within 3 weeks prior to enrollment. 2) Radiation therapy within 2 weeks prior to enrollment. 3) Major surgery within 1 week prior to enrollment. 4) Allogeneic marrow transplant within 1 year to enrollment, or on-going GVHD. 5) Malignant pleural effusion, ascites or cardiac effusion required invasive treatment. 6) Synchronous or asynchronous (within 5 years) other cancer except carcinoma in situ or intramucosal carcinoma. 7) Active infection requires systemic therapy. 8) Active gastrointestinal bleeding required blood transfusion. 9) Any severe and/or uncontrolled medical conditions. severe interstitial pneumonia history. 10) History of severe interstitial pneumonia. 11) Severe psychiatric disorder. 12) Known serious drug allergy. 13) Woman during pregnancy, or impossible to discontine breast-feeding for 120 days after the final dose of study treatment. Patient or the partner without intent to use birth control. 14) Inadequate physical condition judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate after 16 weeks from the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survival Clinical benefit rate after 16 weeks Adverse events | — |
Countries
Japan
Contacts
Public ContactChika Nitani
Osaka City General Hospital Department of Pediatric Hematology/Oncology
Outcome results
None listed