Clinical trial · Interventional
Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
NCT01254838CI-TRIAL-00004166completedPhase 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 safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLA-A02 restricted HIG2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 2 years
- description
- hematological and non-hematological adverse event
Secondary outcomes (1)
- measure
- CTL reaction
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments PATIENTS CHARACTERISTICS 1. Patients who showed resistance to hormonal therapy and chemotherapy 2. Histological diagnosis is adenocarcinoma 3. HLA-A\*0201/0206 4. ECOG performance status of 0 to 2 5. Age ≥ 20 years, ≤80 years 6. WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg 7. life expectancy ≥ 3months 8. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception) 4. Serious infections requiring antibiotics 5. Concomitant treatment with steroids or immunosuppressing agent 6. Other malignancy difficult to control. 7. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available
No reference posted for this study.