Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
Phase 2
Completed
- Conditions
- Neoplasms
- Registration Number
- NCT01734564
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate 8-10 weeks
- Secondary Outcome Measures
Name Time Method Safety (Common Toxicity Criteria 4.0) 8-10 weeks
Trial Locations
- Locations (1)
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Clinica Universidad de Navarra🇪🇸Pamplona, Navarra, Spain