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Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734564
First Posted: November 27, 2012
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
  Purpose
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

Condition Intervention Phase
Neoplasms Biological: Hiltonol and autologous dendritic cells Radiation: Hiltonol, dendritic cells and radiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Response rate [ Time Frame: 8-10 weeks ]

Secondary Outcome Measures:
  • Safety (Common Toxicity Criteria 4.0) [ Time Frame: 8-10 weeks ]

Enrollment: 15
Study Start Date: November 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hiltonol and autologous dendritic cells
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734564


Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: Jose Luis Perez Gracia, MD, PhD Clinica Universidad de Navarra
  More Information

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01734564     History of Changes
Other Study ID Numbers: CD-2010-01
First Submitted: November 21, 2012
First Posted: November 27, 2012
Last Update Posted: April 11, 2017
Last Verified: May 2016

Additional relevant MeSH terms:
Poly ICLC
Poly I-C
Carboxymethylcellulose Sodium
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents