Clinical trial · Interventional
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
NCT02496520CI-TRIAL-00043559DEND/TIAcompletedPhase 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
Summary
Brief summary (as posted)
Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy as needed by the patient´s tumor and stage | Drug | — | UNRESOLVED |
| dendritic cells | Biological | — | UNRESOLVED |
| Radiation therapy as needed by the patient´s tumor and stage | Radiation | — | UNRESOLVED |
| Surgery as needed by the patient´s tumor and stage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccines with autologous dendritic cells
- description
- Vaccines with autologous dendritic cells
- interventionNames
- Biological: dendritic cells
- Procedure: Surgery as needed by the patient´s tumor and stage
- Drug: Chemotherapy as needed by the patient´s tumor and stage
- Radiation: Radiation therapy as needed by the patient´s tumor and stage
Primary outcomes (1)
- measure
- Number and type of adverse events detected in the follow up as a measure of safety and tolerability
- timeFrame
- 24 months
Secondary outcomes (3)
- measure
- Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor * From 3 to 40 years * Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal. Exclusion Criteria: * Toxicity or liver, medullar, renal insufficiency that advise against participation * Pregnant or breast feeding women * Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma * Immunosuppressive treatment * Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection
References
Publications (0)
Data not yet available
No reference posted for this study.