Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01413295|
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : November 4, 2014
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Dendritic Cell Vaccine Other: Supportive treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Dendritic Cells Vaccine
Dendritic Cells Vaccine after 2 lines of chemotherapy
Drug: Dendritic Cell Vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Supportive treatment after 2 lines of chemotherapy
Other: Supportive treatment
Supportive treatment after progression of the illness after 2 lines of chemotherapy
- Progression Free Survival [ Time Frame: 4 months ]
- Overall Survival [ Time Frame: 4 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413295
|Hospital Clínic Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Ramon Vilella, PhD||Fundació Clinic Recerca Biomédica|
|Responsible Party:||Ramon Vilella Puig, Senior consultant, Fundacion Clinic per a la Recerca Biomédica|
|Other Study ID Numbers:||
2009-017247-33 ( EudraCT Number )
TRA-082 ( Other Grant/Funding Number: Ministerio Ciencia e Innovación. SPAIN )
|First Posted:||August 10, 2011 Key Record Dates|
|Last Update Posted:||November 4, 2014|
|Last Verified:||November 2014|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases