Colorectal NeoplasmsPhase 2NCT01413295
Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Dendritic Cell Vaccine and Supportive treatment in people with Colorectal Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Dendritic Cell Vaccine and Supportive treatment
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2011to Sep 2014
- 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.
- Capacity of understanding and signing the informed consent and to undergo the study procedures.
- Previously treated with 2 lines of chemotherapy.
- ECOG <= 2.
- Adequate renal, hepatic and bone marrow function
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy.
- Availability of tumor tissue, for maturing dendritic cells
- RECIST.1 criteria
Who cannot join
- Clinically relevant diseases or infections (HBV, HCV, HIV).
- Pregnant or breast feeding women.
- Immunosuppressant treatment.
- Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.
- Conditions
- Colorectal Neoplasms
- Being tested
- Dendritic Cell Vaccine, Supportive treatment
- Keywords
- Colorectal Neoplasms, 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 Cell VaccineDrug
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Supportive treatmentOther
Supportive treatment after progression of the illness after 2 lines of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cells Vaccine | Experimental | Dendritic Cells Vaccine after 2 lines of chemotherapy Receives: Drug: Dendritic Cell Vaccine |
| Supportive treatment | Other | Supportive treatment after 2 lines of chemotherapy Receives: Other: Supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 4 months
Secondary outcomes (1)
Overall Survival
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Ramon Vilella, PhD, Principal investigator, Fundació Clinic Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413295
- Sponsor's protocol ID
- MCBRVP
- Other IDs
- 2009-017247-33, TRA-082, 2009
- Status last verified
- Nov 2014
- First submitted
- 9 Aug 2011
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment
- ClinicalTrials.gov ID
- NCT01413295
- Acronym / sponsor ID
- MCBRVP
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Dendritic Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Aug 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.
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cells Vaccine | Experimental | Drug: Dendritic Cell VaccineDendritic Cells Vaccine after 2 lines of chemotherapy |
| Supportive treatment | Other | Other: Supportive treatmentSupportive treatment after 2 lines of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 18 years.
- Capacity of understanding and signing the informed consent and to undergo the study procedures.
- Previously treated with 2 lines of chemotherapy.
- ECOG <= 2.
- Adequate renal, hepatic and bone marrow function
Key exclusion criteria (4 listed)
- Clinically relevant diseases or infections (HBV, HCV, HIV).
- Pregnant or breast feeding women.
- Immunosuppressant treatment.
- Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
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 Cell VaccineVaccination with autologous dendritic cells loaded with autologous tumor antigens | Drug | Dendritic Cells Vaccine |
| Supportive treatmentSupportive treatment after progression of the illness after 2 lines of chemotherapy | Other | Supportive treatment |
Primary outcome
Progression Free Survival
Time frame: 4 months
1 secondary outcome
Overall Survival
Time frame: 4 months
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 4 Nov 2014.
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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.
Ramon Vilella, PhD principal investigator
Fundació Clinic Recerca Biomédica
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 Dendritic Cell Vaccine and Supportive treatment in people with Colorectal Neoplasms, run by Fundacion Clinic per a la Recerca Biomédica 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 8 inclusion and 4 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 4 Nov 2014. 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?
Progression Free Survival (time frame: 4 months). 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 4 Nov 2014.