UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032774 |
|---|---|
| Receipt number | R000037366 |
| Scientific Title | Phase 2a study of peptide cocktail vaccine and interferon-beta for patients with refractory pediatric central nervous system tumor |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2019/06/11 16:48:22 |
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Basic information
Public title
Phase 2a study of peptide cocktail vaccine and interferon-beta for patients with refractory pediatric central nervous system tumor
Acronym
NCCV+IFN-beta p2a
Scientific Title
Phase 2a study of peptide cocktail vaccine and interferon-beta for patients with refractory pediatric central nervous system tumor
Scientific Title:Acronym
NCCV+IFN-beta p2a
Region
| Japan |
Condition
Condition
refractory pediatric central nervous system tumors
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of peptide anticancer cocktail vaccine "NCCV Cocktail-1" combined with interferon-beta 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
| Medicine | Vaccine |
Interventions/Control_1
NCCV Cocktail-1 is administered by subcutaneous injection weekly for the first 8 weeks and then administered biweekly.
IFN-beta is administrated by intravenous administration five times a week for the first 2 weeks and then administrated once a week.
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 glioma or medulloblastoma and diffuse intrinsic pontine glioma diagnosed on images.
2) aged 30 or less
3) Medical history of standard therapy
4) In the imaging examination within 28 days, at least one neoplastic lesion was confirmed and all lesions was no change or was progressive compared with the comparable latest imaging examination more than 21 days ago from the latest image
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 3 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
13
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
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
c-tanaka@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 30 | 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
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | 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
| 2018 | Year | 05 | Month | 30 | 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=R000037366
