Phase I study of peptides derived from novel cancer antigens for advanced colorectal cancer
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000004948
- Lead Sponsor
- Yamaguchi University Graduate School of Medicine, Digestive surgery and surgical oncology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and to find the recommended dose
- Secondary Outcome Measures
Name Time Method Immunological effect Objective responses Overall survival