Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer
Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started May 2007
Typical duration for phase_1 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 12, 2015
May 1, 2015
4.2 years
March 17, 2008
May 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (toxicities as assessed by NCI CTCAE version 3)
2 months
Secondary Outcomes (1)
Specific CTL induction in vitro, Objective rate as assessed by RECST criteria
2 months
Study Arms (1)
Phase 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ECOG performance status 0-1
- Life expectancy \> 3 months
- HLA A24 positive
- Histologically diagnosed as colorectal cancer with measurable lesion
- Laboratory values as follows:WBC\>3000/mm3, Hb\>10mg/dl, Plt\>75000/mm3, Creatinine\<1.2mg/dl, T. bil.\<1.5mg/dl, AST, ALT\<3x normal limits
- Able and willing to give valid written informed consent
You may not qualify if:
- Active other malignancy
- Active infection
- Immune deficiency
- Current treatment with steroids and immunosuppressive agents
- Pregnancy and breast feeding
- Inability oral intake
- Psychic disease
- Hepatitis B, C virus
- HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Women's Medical University Medical Center East
Tokyo, 116-8567, Japan
Related Publications (2)
Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.
PMID: 15623641BACKGROUNDYoshimatsu K, Yokomizo H, Fujimoto T, Umehara A, Otani T, Matsumoto A, Osawa G, Ogawa K. Pilot study of simplified low-dose S-1 plus CPT-11 as first-line chemotherapy for patients with advanced colorectal cancer. Anticancer Res. 2007 May-Jun;27(3B):1657-61.
PMID: 17595792BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuhiko Yoshimatsu, MD
Tokyo Women's Medical University Medical Center East
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ascociate professor of surgery
Study Record Dates
First Submitted
March 17, 2008
First Posted
March 24, 2008
Study Start
May 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
May 12, 2015
Record last verified: 2015-05