Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Phase 2

Completed

• Conditions: Neoplasms
• Interventions: Biological: Hiltonol and autologous dendritic cells; Radiation: Hiltonol, dendritic cells and radiation

• 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Status Verified: 2016-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

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

Arm && Interventions

Group	Intervention	Description
Hiltonol and autologous dendritic cells	Hiltonol and autologous dendritic cells	Hiltonol and autologous dendritic cells
Hiltonol, dendritic cells and radiation	Hiltonol, dendritic cells and radiation	Hiltonol, dendritic cells and radiation.

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