UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010149 |
|---|---|
| Receipt number | 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 12:22:00 |
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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
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
nccv_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011667
