Clinical trial NCT00676949: Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
Official title: Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Tumors
Keywords: epitope peptide
cyclophosphamide
interleukin-2
Lead sponsor: Kyushu University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2008-05-13
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
timeFrame: 2 years
Secondary outcomes:
measure: immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
Study officials:
affiliation: Medical Institute of Bioregulation, Kyushu University
name: Kenzaburo Tani, MD,phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.