- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01413295
Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
November 3, 2014 updated by: Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08036
- Hospital Clinic Barcelona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dendritic Cells Vaccine
Dendritic Cells Vaccine after 2 lines of chemotherapy
|
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
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OTHER: Supportive treatment
Supportive treatment after 2 lines of chemotherapy
|
Supportive treatment after progression of the illness after 2 lines of chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ramon Vilella, PhD, Fundació Clinic Recerca Biomédica
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
August 9, 2011
First Submitted That Met QC Criteria
August 9, 2011
First Posted (ESTIMATE)
August 10, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBRVP
- 2009-017247-33 (EUDRACT_NUMBER)
- TRA-082 (OTHER_GRANT: Ministerio Ciencia e Innovación. SPAIN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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