Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
peptidevac
Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
2 other identifiers
interventional
18
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 23, 2011
April 1, 2011
2.3 years
March 3, 2008
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
2 years
Secondary Outcomes (1)
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
2.5 years
Study Arms (1)
1
EXPERIMENTALcyclophosphamide 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.
Interventions
1mg each of 5 peptides with IFA. 4 weekly s.c. administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Related Publications (1)
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.
PMID: 15930316BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenzaburo Tani, MD,phD
Medical Institute of Bioregulation, Kyushu University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2008
First Posted
May 13, 2008
Study Start
November 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 23, 2011
Record last verified: 2011-04