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Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (toxicities as assessed by NCI CTCAE version 3)

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Kazuhiko Yoshimatsu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tokyo Women's Medical University Medical Center East

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TWMU1035

NCT ID:

NCT00641615

Start Date:

May 2007

Completion Date:

March 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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