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Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors (peptidevac)

Primary Purpose

Metastatic Tumors

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
Sponsored by
Kyushu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Tumors focused on measuring epitope peptide, cyclophosphamide, interleukin-2

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyushu University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level.

Outcomes

Primary Outcome Measures

safety of the cyclophosphamide combined tumor specific epitope peptide cocktail

Secondary Outcome Measures

immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail

Full Information

First Posted
March 3, 2008
Last Updated
June 22, 2011
Sponsor
Kyushu University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00676949
Brief Title
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
Acronym
peptidevac
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyushu University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Tumors
Keywords
epitope peptide, cyclophosphamide, interleukin-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level.
Intervention Type
Biological
Intervention Name(s)
5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
Other Intervention Name(s)
5 peptide cocktail
Intervention Description
1mg each of 5 peptides with IFA. 4 weekly s.c. administration.
Primary Outcome Measure Information:
Title
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
Time Frame
2 years
Secondary Outcome Measure Information:
Title
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenzaburo Tani, MD,phD
Organizational Affiliation
Medical Institute of Bioregulation, Kyushu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15930316
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.
Results Reference
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Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors

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