Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

April 10, 2017 updated by: Clinica Universidad de Navarra, Universidad de Navarra
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hiltonol and autologous dendritic cells
Biological: Hiltonol and autologous dendritic cells
Hiltonol and autologous dendritic cells
EXPERIMENTAL: Hiltonol, dendritic cells and radiation
Hiltonol, dendritic cells and radiation.
Radiation: Hiltonol, dendritic cells and radiation
Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 8-10 weeks
8-10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety (Common Toxicity Criteria 4.0)
Time Frame: 8-10 weeks
8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Jose Luis Perez Gracia, MD, PhD, Clinica Universidad de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (ESTIMATE)

November 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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