Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms
Both
Neoplasms
Trial Information
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
8-10 weeks
Safety Issue:
No
Principal Investigator
Jose Luis Perez Gracia, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinica Universidad de Navarra
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
CD-2010-01
NCT ID:
NCT01734564
Start Date:
November 2012
Completion Date:
December 2014
Related Keywords:
- Neoplasms
- Neoplasms
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