Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors - Full Text View

Sponsored by:	University of Navarre
Information provided by:	University of Navarre
ClinicalTrials.gov Identifier:	NCT00610389

Purpose

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.

Condition	Intervention	Phase
Renal Cell Carcinoma Melanoma Carcinoma, Hepatocellular	Biological: immunotherapy with dendritic cells	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors

Further study details as provided by University of Navarre:

Primary Outcome Measures:

Response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunological response [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	27
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610389

Contacts

Contact: Ignacio Melero, MD, PhD

+34 948255400

imelero@unav.es

Locations

Spain, Navarra
Oncology Department. Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008

Sponsors and Collaborators

University of Navarre

Investigators

Principal Investigator:

Ignacio Melero, MdPhD

University of Navarre

More Information

Responsible Party:	Universidad de Navarra ( Ignacio Melero Bermejo )
Study ID Numbers:	CD-2007-01
Study First Received:	January 28, 2008
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00610389
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Liver Diseases
Carcinoma, Hepatocellular
Liver neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Kidney cancer
Melanoma
Liver Neoplasms
Urologic Diseases
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Kidney Diseases

Interferon-alpha
Digestive System Neoplasms
Renal cancer
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Digestive System Diseases
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Nevus
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 15, 2009