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Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)


Phase 1
20 Years
80 Years
Not Enrolling
Both
Metastatic Tumors

Thank you

Trial Information

Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)


KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression
profile analysis by the use of cDNA microarray in the previous studies. The investigators
have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1,
TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated
with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore,
when vaccinated these peptides, specific CTLs were determined after the vaccination.
Therefore the investigators focused on the prevention of further expansion of the solid
tumors highly expressing these 5 proteins using these 5 peptides.


Inclusion Criteria:



- clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical
cancer patients

- performance status 0-1

- age between 20 and 80

- at least 4 weeks after previous therapy

- life expectancy more than 3 months

- permissible bone marrow, liver and renal function

- HLA-A2402

- no viral hepatitis, HIV or HTLV1

Exclusion Criteria:

- severe underlying disease

- pregnant or lactating women

- active brain metastasis

- uncontrollable infection

- under systemic corticosteroid or immune suppressant treatment

- history of allergy to epitope peptides or IFA

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

safety of the cyclophosphamide combined tumor specific epitope peptide cocktail

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Kenzaburo Tani, MD,phD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Institute of Bioregulation, Kyushu University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

KU-CY5peptides

NCT ID:

NCT00676949

Start Date:

November 2007

Completion Date:

March 2010

Related Keywords:

  • Metastatic Tumors
  • epitope peptide
  • cyclophosphamide
  • interleukin-2
  • Neoplasm Metastasis

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