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Completed

NCT Number: NCT01734564

Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hiltonol and autologous dendritic cells

Biological

Hiltonol and autologous dendritic cells

Hiltonol, dendritic cells and radiation

Radiation

Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.

Primary outcomes

  1. Response rate

    Time frame: 8-10 weeks

Secondary outcomes

  1. Safety (Common Toxicity Criteria 4.0)

    Time frame: 8-10 weeks

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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