UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004948 |
|---|---|
| Receipt number | R000005891 |
| Scientific Title | Phase I study of peptides derived from novel cancer antigens for advanced colorectal cancer |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2011/07/27 21:13:16 |
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Basic information
Public title
Phase I study of peptides derived from novel cancer antigens for advanced colorectal cancer
Acronym
Phase I study of peptides for advanced colorectal cancer
Scientific Title
Phase I study of peptides derived from novel cancer antigens for advanced colorectal cancer
Scientific Title:Acronym
Phase I study of peptides for advanced colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluated the safety of subcutaneous injection of HLA-A*2402 restricted epitope peptides (RNF43, TOMM34, KOC1, VEGFR1 and VEGFR2).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety and to find the recommended dose
Key secondary outcomes
Immunological effect
Objective responses
Overall survival
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
dose escalation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Unrespectable metastatic colorectal cancer and resistant for standard therapy.
2. Performance status 0-2 (ECOG)
3. Evaluable tumor lesion(s)
4. No major surgery, radiotherapy, or chemotherapy within 4 weeks prior to the study
5. predicted life expectancy of at least 3 months
6. Adequate baseline organ functions, defined as a leukocyte count of at least 2000 ⁄ lL, platelet count of at least 75000 / lL, and aspartate aminotransferase and alanine aminotransferase levels three times or less than the upper limit of the institutional reference range; and serum creatinine below 2.0 mg⁄ dL.
7. with HLA-A2402
8. Written informed consent.
Key exclusion criteria
Serious infectious disease or other severe complications (e.g. pulmonary fibrosis / interstitial pneumonia, uncontrollable diabetes); pregnancy or lactation, or trying to get pregnant; a history of drug allergy
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Digestive surgery and surgical oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Hazama |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Digestive surgery and surgical oncology
Zip code
Address
TEL
Homepage URL
hazama@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Digestive surgery and surgical oncology
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine, Digestive surgery and surgical oncology
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=77482
Number of participants that the trial has enrolled
Results
Background A phase I clinical trial was conducted for patients with mCRC using 5 novel HLA-A24-restricted peptides, which were derived from 3 oncoantigens (RNF43 TOMM34 KOC1), and from VEGFR1 and VEGFR2. Methods: This study was conducted to evaluate the safety and to find the recommended dose of the combination of 5 peptides, and secondary to evaluate immunological and antitumor effects. Eighteen HLAA2402positive mCRC pts who failed to standard therapy were enrolled in this study with written informed consents. Each of the 5 peptides was subcutaneously injected with 0.5 mL of incomplete Freunds adjuvant (IFA) to the inguinal or axillal regions in 5 separate regions weekly for 4 weeks in a dose-escalation manner (doses of 0.5, 1, and 3 mg each peptide/ body, 3 pts cohort).Results: The vaccination was well tolerated without any treatment associated adverse events of grade 2 or higher. The total numbers of peptides induced antigen specific response were 2 peptides in 3 pts at 0.5mg, 6 in 3 pts at 1.0 mg, and 18 in 6pts at 3.0 mg, respectively. We therefore decided that the RD was 3.0 mg / body.
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
| 2006 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2011 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005891
