NCT00610389|UnknownPhase 2
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Sponsor study identifier
interventional
27
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: cellular immunotherapy with dendritic cells (DC) loaded with tumor antigens has shown clinical activity, although in a small number of patients. Therefore, is is mandatory to improve the results of this strategy and to closely monitor immunologic response and cell migration in order to improve our understanding of mechanisms of action and to settle future fields of development.. Objectives: Primary: to confirm clinical activity of this strategy, determining tumor response (RECIST criteria). Secondary: to determine: (1) safety; (2) antitumoral immune response and (3) DC migration in the organism Methodology: phase II trial in patients with advanced renal cell carcinoma and melanoma. We will perform repeated immunizations with DC loaded with the patient´s tumor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2008
Actual (reported)February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 8, 2008
Actual (reported)April 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Response rate
2 months
Immunological response
2 months
We will administer four daily doses (repeated every 24 hours)o dendritic cells in two cycles one month apart. We will administer systemic treatment with PEG-IFN alfa and GM-CSF to potentiate activity.
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Oncology Department. Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Ignacio Melero, MdPhD
University of Navarra
First Submitted
January 28, 2008
First Posted
February 8, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Estimated (date passed)Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 10, 2010
Record last verified: 2010-05
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Source: ClinicalTrials.gov.
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