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Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00610389
First received: January 28, 2008
Last updated: May 7, 2010
Last verified: May 2010
History of Changes

January 28, 2008
May 7, 2010
February 2008
April 2010   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610389 on ClinicalTrials.gov Archive Site
Immunological response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors
Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors

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.

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 (through study of delayed hypersensitivity; ELISPOT; activity of Natural Killer cells; and serum cytokine concentrations); and (3) DC migration in the organism, by labeling with 111-Indium oxinate

Methodology: phase II trial in patients with advanced renal cell carcinoma and melanoma. We will perform repeated immunizations with mature DC loaded with autologous tumor. We will introduce the following novel elements to enhance efficacy (1) Pre-treatment with cyclophosphamide to reduce regulatory / suppressor T cells; (2) maturation/activation of DC induced by TNF-alfa, IFN-alfa and double stranded RNA (GMP-manufactured poly I:C), aimed at replication of the phenomena observed during a viral infection (3) intranodal DC administration in inguinal lymph nodes (4) four daily doses (repeated every 24 hours) in two cycles one month apart (5) scintigraphic follow-up of a tracing dose of 111-In labelled DC and (6) ) systemic treatment with PEG-IFN alfa and GM-CSF to potentiate activity.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Carcinoma
  • Melanoma
  • Carcinoma, Hepatocellular
Biological: immunotherapy with dendritic cells
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.
Experimental: 1
Intervention: Biological: immunotherapy with dendritic cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
December 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of metastatic melanoma, renal cell carcinoma, or hepatocarcinoma (Child´s stage A or B) not amenable of curative treatment. For patients with hepatocarcinoma, treatment after embolization is allowed
  • Measurable disease
  • ECOG 0, 1 or 2.
  • Adequate renal, hepatic and bone marrow function
  • Availability of tumor tissue, for maturing dendritic cells

Exclusion Criteria:

  • 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 PI.
  • Pregnant or breast feeding women
  • immunosuppressant treatment
  • known CNS metastasis
Both
18 Years and older
No
Contact: Ignacio Melero, MD, PhD +34 948255400 imelero@unav.es
Spain
 
NCT00610389
CD-2007-01
No
Ignacio Melero Bermejo, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Not Provided
Principal Investigator: Ignacio Melero, MdPhD University of Navarra
Clinica Universidad de Navarra, Universidad de Navarra
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP