NeoplasmsPhase 2NCT01734564
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
A Phase 2 study testing Hiltonol and autologous dendritic cells and Hiltonol, dendritic cells and radiation in people with Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Hiltonol and autologous dendritic cells and Hiltonol, dendritic cells and radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Hiltonol and autologous dendritic cells, Hiltonol, dendritic cells and radiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiltonol and autologous dendritic cellsBiological
Hiltonol and autologous dendritic cells
Hiltonol, dendritic cells and radiationRadiation
Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.
| Study group | Role | What they receive |
|---|---|---|
| Hiltonol and autologous dendritic cells | Experimental | Hiltonol and autologous dendritic cells Receives: Biological: Hiltonol and autologous dendritic cells |
| Hiltonol, dendritic cells and radiation | Experimental | Hiltonol, dendritic cells and radiation. Receives: Radiation: Hiltonol, dendritic cells and radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 8-10 weeks
Secondary outcomes (1)
Safety (Common Toxicity Criteria 4.0)
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Luis Perez Gracia, MD, PhD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734564
- Sponsor's protocol ID
- CD-2010-01
- Status last verified
- May 2016
- First submitted
- 21 Nov 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
- ClinicalTrials.gov ID
- NCT01734564
- Acronym / sponsor ID
- CD-2010-01
- Conditions
- Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hiltonol and autologous dendritic cells | Experimental | Biological: Hiltonol and autologous dendritic cellsHiltonol and autologous dendritic cells |
| Hiltonol, dendritic cells and radiation | Experimental | Radiation: Hiltonol, dendritic cells and radiationHiltonol, dendritic cells and radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hiltonol and autologous dendritic cellsHiltonol and autologous dendritic cells | Biological | Hiltonol and autologous dendritic cells |
| Hiltonol, dendritic cells and radiationHiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect. | Radiation | Hiltonol, dendritic cells and radiation |
Primary outcome
Response rate
Time frame: 8-10 weeks
1 secondary outcome
Safety (Common Toxicity Criteria 4.0)
Time frame: 8-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Perez Gracia, MD, PhD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hiltonol and autologous dendritic cells and Hiltonol, dendritic cells and radiation in people with Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 8-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.