Colorectal CarcinomaPhase 2NCT01348256
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
A Phase 2 study testing Dendritic cells vaccine in people with Colorectal Carcinoma and Hepatic Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Hepatic Metastasis
- What is being tested?
- Dendritic cells vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2010to Dec 2018
- 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
- Age over 18 years.
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
- Capacity of understanding and signing the informed consent and to undergo the study procedures
- Availability of tumor tissue, for maturing dendritic cells
- Adequate renal, hepatic and bone marrow function
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 principal investigator (PI).
- Pregnant or breast feeding women
- Immunosuppressant treatment
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Ignacio Melero, MD, PhD
- Recruiting
Hospital de Navarra
Pamplona, Navarre, 31008
Ruth Vera, MD
About this study
Official title: Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.
- Conditions
- Colorectal Carcinoma, Hepatic Metastasis
- Being tested
- Dendritic cells vaccine
- Keywords
- colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cells vaccineDrug
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation after standard treatment |
| Dendritic cells vaccine | Experimental | Adjuvant treatment with dendritic cells vaccine after standard treatment Receives: Drug: Dendritic cells vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Measured: Progression free survival at 2 years
Secondary outcomes (1)
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio Melero, MDPhD, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348256
- Sponsor's protocol ID
- CD-2009-01
- Other IDs
- 2008-007795-23, 2008
- Status last verified
- Oct 2017
- First submitted
- 3 May 2011
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.
PubMed 30268156
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT01348256
- Acronym / sponsor ID
- CD-2009-01
- Conditions
- Colorectal Carcinoma, Hepatic Metastasis
- Keywords
- colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 May 2011 (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 randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Observation after standard treatment |
| Dendritic cells vaccine | Experimental | Drug: Dendritic cells vaccineAdjuvant treatment with dendritic cells vaccine after standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years.
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
- Capacity of understanding and signing the informed consent and to undergo the study procedures
- Availability of tumor tissue, for maturing dendritic cells
- Adequate renal, hepatic and bone marrow function
Key exclusion criteria (5 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 principal investigator (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 |
|---|---|---|
| Dendritic cells vaccineVaccination with autologous dendritic cells loaded with autologous tumor antigens | Drug | Dendritic cells vaccine |
Primary outcome
Progression Free survival
Time frame: Progression free survival at 2 years
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 30268156Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.
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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.
Ignacio Melero, MDPhD study chair
University of Navarra
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dendritic cells vaccine in people with Colorectal Carcinoma and Hepatic Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Melero, MD, PHD (+34 948 255 400, imelero@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free survival (time frame: Progression free survival at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348256, which also lists 1 linked publication.
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 24 Oct 2017.