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: August 30, 2013
Last verified: August 2013
  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:


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
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

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: August 30, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on October 19, 2014