UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1 study of peptide cocktail vaccine for patients with refractory pediatric sarcoma.
Acronym	NCCV Cocktail-1
Scientific Title	Phase 1 study of peptide cocktail vaccine for patients with refractory pediatric sarcoma.
Scientific Title:Acronym	NCCV Cocktail-1
Region	Japan

Condition
Condition	refractory neurobrastoma, Ewing's sarcoma family of tumor, rhabdomyosarcoma and osteosarcoma
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine a recommend dose of peptide anticancer cocktail vaccine "NCCV Cocktail-1" in patients with refractory neurobrastoma, Ewing's sarcoma family of tumor, rhabdomyosarcoma and osteosarcoma.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of dose limiting toxicity (DLT)
Key secondary outcomes	Adverse events: AE Disease control rate: DCR Progression free survival: PFS Overall survival: OS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	NCCV Cocktail-1 is administered weekly by subcutaneous injection, for a maximum of 1 year.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key 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
Key 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.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ako Hosono
Organization	National Cancer Center Hospital East
Division name	Pediatric Oncology Division
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	nccv_core@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Ako Hosono
Organization	National Cancer Center Hospital East
Division name	Pediatric Oncology Division
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	nccv_core@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shionogi & Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	独立行政法人国立がん研究センター東病院（千葉県） 独立行政法人国立がん研究センター中央病院（東京都） 大阪市立総合医療センター（大阪府） 聖路加国際病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 18 Day
Date of IRB	2012 Year 12 Month 26 Day
Anticipated trial start date	2013 Year 03 Month 06 Day
Last follow-up date	2014 Year 12 Month 26 Day
Date of closure to data entry	2015 Year 01 Month 20 Day
Date trial data considered complete	2015 Year 01 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Other
Other related information	Cancer Science

Management information
Registered date	2013 Year 03 Month 01 Day
Last modified on	2019 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011667