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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010149
Receipt No. R000011667
Scientific Title Phase 1 study of peptide cocktail vaccine for patients with refractory pediatric sarcoma.
Date of disclosure of the study information 2013/03/01
Last modified on 2019/09/30

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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