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Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01734564
First received: November 21, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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
 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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: November 21, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013