Clinical trial NCT00641615: Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer
Official title: Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Lead sponsor: Tokyo Women's Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2008-03-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: RNF43 is a cancer testis antigen which express widely in colorectal cancer tissue but not in normal organs. RNF43-721 induces HLA A24 restricted specific cytotoxic T lymphocytes (CTL) against RNF43 expressed target. S-1/CPT-11 chemotherapy is performed unresectable advanced colorectal cancer in Japan and is reported to be obtained almost the same result compared with FOLFOX or FOLFIRI as first-line chemotherapy for advanced colorectal cancer. Because synergistic effect between vaccine therapy and chemotherapy will be expected, we plan phase I study 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety (toxicities as assessed by NCI CTCAE version 3)
timeFrame: 2 months
Secondary outcomes:
measure: Specific CTL induction in vitro, Objective rate as assessed by RECST criteria
timeFrame: 2 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Medical Center East
Study officials:
affiliation: Tokyo Women's Medical University Medical Center East
name: Kazuhiko Yoshimatsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yoshimatsu 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.