Clinical trial · Interventional
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
NCT00676949CI-TRIAL-00005074peptidevaccompletedPhase 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 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
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 |
|---|---|---|---|
| Metastatic Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- 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.
- interventionNames
- Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
Primary outcomes (1)
- measure
- safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- 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