NCT01734564

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

May 1, 2016

Enrollment Period

4.1 years

First QC Date

November 21, 2012

Last Update Submit

April 10, 2017

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate

    8-10 weeks

Secondary Outcomes (1)

  • Safety (Common Toxicity Criteria 4.0)

    8-10 weeks

Study Arms (2)

Hiltonol and autologous dendritic cells

EXPERIMENTAL

Hiltonol and autologous dendritic cells

Biological: Hiltonol and autologous dendritic cells

Hiltonol, dendritic cells and radiation

EXPERIMENTAL

Hiltonol, dendritic cells and radiation.

Radiation: Hiltonol, dendritic cells and radiation

Interventions

Hiltonol and autologous dendritic cellsBIOLOGICAL

Hiltonol and autologous dendritic cells

Hiltonol and autologous dendritic cells
Hiltonol, dendritic cells and radiationRADIATION

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

Hiltonol, dendritic cells and radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

poly ICLCRadiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Jose Luis Perez Gracia, MD, PhD

    Clinica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2017

Record last verified: 2016-05

Locations

ES(1)