Clinical trial · Interventional
HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
NCT01266720CI-TRIAL-00004225unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| VEGFR1, VEGFR2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1 study
- description
- Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
- interventionNames
- Biological: VEGFR1, VEGFR2
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Toxicities as assessed by NCI-CACAE ver3
- timeFrame
- 3 months
Secondary outcomes (6)
- measure
- Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
- timeFrame
- 3 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer * Measurable disease by CT scan * ECOG performance status 0-2 * Life expectancy \> 3 months * laboratory values as follows: 2,000/mm3 \< WBC \< 15,000/mm3, Platelet count \>75,000/mm3, Total Bilirubin \<1.5 mg/dl, Asparate transaminase \<150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl * HLA-A\*0201 * Able and willing to give valid written infromed consent Exclusion Criteria: * Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) * Breast-feeder * Active or uncontrolled infection * Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks * Serious or uncured wound * Active or uncontrolled other malignancy * Steroids or immunosuppressing agent dependent status * Interstitial pneumonia * Ileus * Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (3)
- BACKGROUNDNiethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4. PMID 12415261
- BACKGROUNDIshizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750. PMID 17020992
- BACKGROUNDWada 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 15930316