UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022607
Receipt number 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 16:47:09

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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 or person

Institute

Osaka City General Hospital

Institute

Department

Personal name



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

Value
https://center6.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