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Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01734564
First received: November 21, 2012
Last updated: May 10, 2016
Last verified: May 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 25
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734564

Contacts
Contact: Jose Luis Perez Gracia, MD, PhD +34948255400 ext 5825 jlgracia@unav.es

Locations
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Jose Luis Perez Gracia, MD, PhD         
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 
Study First Received: November 21, 2012
Last Updated: May 10, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on December 09, 2016