Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors
18 Years
N/A
Both
Renal Cell Carcinoma, Melanoma, Carcinoma, Hepatocellular
Trial Information
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 (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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
Ignacio Melero, MdPhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Navarra
Authority:
Spain: Spanish Agency of Medicines
Study ID:
CD-2007-01
NCT ID:
NCT00610389
Start Date:
February 2008
Completion Date:
December 2010
Related Keywords:
- Renal Cell Carcinoma
- Melanoma
- Carcinoma, Hepatocellular
- Carcinoma
- Carcinoma, Renal Cell
- Melanoma
- Carcinoma, Hepatocellular
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