Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Neoplasms Clinical Trial

Official title:

Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734564
• Other study ID #: CD-2010-01
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2012
• Last updated: April 10, 2017
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Biological:
• Hiltonol and autologous dendritic cells
Hiltonol and autologous dendritic cells

Radiation:
• Hiltonol, dendritic cells and radiation
Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		8-10 weeks
Secondary	Safety (Common Toxicity Criteria 4.0)		8-10 weeks