UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022607
Receipt No. R000025021
Scientific Title Phase 2a study of peptide cocktail vaccine for patients with refractory pediatric central nervous system tumor
Date of disclosure of the study information 2016/06/07
Last modified on 2019/06/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase 2a study of peptide cocktail vaccine for patients with refractory pediatric central nervous system tumor
Acronym NCCV-CNS p2a
Scientific Title Phase 2a study of peptide cocktail vaccine for patients with refractory pediatric central nervous system tumor
Scientific Title:Acronym NCCV-CNS p2a
Region
Japan

Condition
Condition refractory pediatric central nervous system tumors
Classification by specialty
Hematology and clinical oncology Pediatrics Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of peptide anticancer cocktail vaccine "NCCV Cocktail-1" in patients with refractory pediatric central nervous system tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate after 16 weeks from the start of the treatment
Key secondary outcomes Progression free survival
Overall survival
Clinical benefit rate after 16 weeks
Adverse events

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 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
30 years-old >
Gender Male and Female
Key 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
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) 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hara
Organization Osaka City General Hospital
Division name Department of Pediatric Hematology/Oncology
Zip code
Address 2-13-22 Miyakojima-hondori Miyakojima-ku Osaka 534-0021 JAPAN
TEL 06-6929-1221
Email j-hara@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chika Nitani
Organization Osaka City General Hospital
Division name Department of Pediatric Hematology/Oncology
Zip code
Address 2-13-22 Miyakojima-hondori Miyakojima-ku Osaka 534-0021 JAPAN
TEL 06-6929-1221
Homepage URL
Email c-tanaka@med.osakacity-hp.or.jp

Sponsor
Institute Osaka City General Hospital
Institute
Department

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

Other related organizations
Co-sponsor
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 九州大学病院(福岡県)、兵庫県立こども病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 07 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 Terminated
Date of protocol fixation
2015 Year 05 Month 21 Day
Date of IRB
2019 Year 03 Month 31 Day
Anticipated trial start date
2016 Year 06 Month 08 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 04 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.