Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

University of Navarra

Status and phase

Completed

Phase 2

Conditions

Neoplasms

Treatments

Radiation: Hiltonol, dendritic cells and radiation

Biological: Hiltonol and autologous dendritic cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01734564

CD-2010-01

Details and patient eligibility

About

In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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