refractory neurobrastoma, Ewing'
Conditions
Interventions
NCCV Cocktail-1 is administered weekly by subcutaneous injection, for a maximum of 1 year.
Sponsors
National Cancer Center Hospital East
Shionogi &
Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven neuroblastoma, Ewing's sarcoma family of tumor, rhabdomyosarcoma or osteosarcoma. 2) Refractory to further treatment by the following reason. i. failure to induce remission, recurrent or intolerance in 2nd or later chemotherapy. ii. induced remission in 2nd or later chemotherapy. 3) aged 40 or less 4) ECOG Performance Status of 0-1, or 2-3 due to neurological disorder or limb loss. 5) HLA-A*24:02 positive. 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 or <= 400 IU/L with liver metastasis. v. ALT <= 200 IU/L or <= 400IU/L with liver metastasis. 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
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) Severe psychiatric disorder. 11) Known serious drug allergy. 12) 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. 13) Inadequate physical condition judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events: AE Disease control rate: DCR Progression free survival: PFS Overall survival: OS | — |
Countries
Japan
Contacts
Public ContactAko Hosono
National Cancer Center Hospital East Pediatric Oncology Division
Outcome results
None listed