Neoplasms
Conditions
Brief summary
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.
Detailed description
In this phase II study, patients with solid tumors will receive treatment with intratumoral hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and administered subcutaneously. A new cohort will explore the role of radiation therapy, looking for an abscopal effect.
Interventions
BIOLOGICALHiltonol and autologous dendritic cells
Hiltonol and autologous dendritic cells
RADIATIONHiltonol, dendritic cells and radiation
Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of advanced solid tumors * Measurable disease * Performance status 0, 1 or 2. * Adequate renal, hepatic and bone marrow function * Availability of tumor tissue, for maturing dendritic cells
Exclusion criteria
* Clinically relevant diseases or infections. * concurrent participation in other clinical trial or administration or other antitumoral treatment * Concurrent cancer, with the exceptions allowed by the PI. * Pregnant or breast feeding women * immunosuppressant treatment * known uncontrolled central nervous system metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 8-10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety (Common Toxicity Criteria 4.0) | 8-10 weeks |
Countries
Spain
Outcome results
None listed