Clinical trial · Interventional
Platin-based Chemotherapeutics to Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients
Immunochemotherapy: Do Platin-based Chemotherapeutics Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients?
NCT02285413CI-TRIAL-00022007completedPhase 2ClinicalTrials.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)
This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DC vaccination | Biological | — | UNRESOLVED |
| DC vaccination with cisplatinum | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DC vaccination
- description
- mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase
- interventionNames
- Biological: DC vaccination
- type
- EXPERIMENTAL
- label
- DC vaccination with cisplatinum
- description
- mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase. each DC vaccine will be preceded by cisplatin infusion: 50 mg/m2, 1-2h before DC injection.
- interventionNames
- Biological: DC vaccination with cisplatinum
Primary outcomes (2)
- measure
- Immunogenicity: number of participants with KLH and/or tumor-specific antigens immune responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: All patients: * histologically documented evidence of melanoma * stage III or IV melanoma according to the 2001 AJCC criteria * melanoma expressing gp100. Tyrosinase is not mandatory but will be assessed. * WHO performance status 0-1 (Karnofsky 100-70) * life expectancy ≥3 months * age 18-70 years * no clinical signs or symptoms of CNS metastases * WBC \>3x10\^9/l, lymphocytes \>0.8x10\^9/l, platelets \>100x10\^9/l, serum creatinine \<150 µmol/l, serum bilirubin \<25 µmol/l * normal serum LDH (\<450 U/l) * expected adequacy of follow-up * no pregnant or lactating women * written informed consent and in addition: Stage III melanoma * radical regional lymphnode dissection is performed Stage IV melanoma * at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments Exclusion Criteria: * any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed more than 4 weeks prior to planned vaccination * history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix * serious active infections, known HbsAg or HIV positive, or autoimmune diseases or organ allografts * concomitant use of immunosuppressive drugs * known allergy to shell fish (since it contains KLH) * rapidly progressive symptomatic disease * any serious clinical condition that may interfere with the safe administration of DC
References
Publications (0)
Data not yet available
No reference posted for this study.