Clinical trial · Interventional
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer
Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer
NCT00678509CI-TRIAL-00002945terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of financial support
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptide TTK emulsified with Montanide ISA 51.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTK peptide mixed with Montanide ISA 51 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Biological: TTK peptide mixed with Montanide ISA 51
Primary outcomes (1)
- measure
- safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: feasibility as evaluated by RECIST)
- timeFrame
- 2 months
Secondary outcomes (1)
- measure
- to evaluate immunological responses
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or recurrent breast cancer * Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive * ECOG performance status 0-2 * Life expectancy \> 3 months * HLA-A\*2402 * Laboratory values as follows * 2000/mm3\<WBC\<15000/mm3 * Platelet count\>100000/mm3 * Bilirubin \< 3.0mg/dl * Asparate transaminase \< 150IU/L * Alanine transaminase \< 150IU/L * Creatinine \< 3.0mg/dl * Able and willing to give valid written informed consent Exclusion Criteria: * Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception) * Breastfeeding * Active or uncontrolled infection * Concurrent treatment with steroids or immunosuppressing agent * Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks * Uncontrolled brain and/or intraspinal * Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available
No reference posted for this study.