Safety Study of Cancer Specific Epitope Peptides Cocktail... | NCT00676949

Studies
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors

NCT00676949

Sponsor

Kyushu University

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Metastatic Tumors

Interventions

5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
19-40	Other Identifier	Kyushu University, Japan

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 3, 2008

First Submission Date that Met QC Criteria

May 9, 2008

First Posted Date

May 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
Human Genome Center, Institute of Medical Science, University of Tokyo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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.	Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1	Biological	1mg each of 5 peptides with IFA. 4 weekly s.c. administration.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail		2 years

Secondary Outcomes

Measure	Description	Time Frame
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail		2.5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenzaburo Tani, MD,phD	Medical Institute of Bioregulation, Kyushu University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyushu University Hospital		Fukuoka	Fukuoka	812-8582	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15930316	Background	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.

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C525725	LY6K protein, human
C584411	DEPDC1 protein, human
C438388	KIF20B protein, human