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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00610389 |
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Date of registration:
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28/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors
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Scientific title:
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Phase II Study With Immunotherapy With Dendritic Cells and Tumor Infiltrating Lymphocytes in Solid Tumors |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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27 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00610389 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Ignacio Melero, MD, PhD |
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Address:
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Telephone:
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+34 948255400 |
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Email:
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imelero@unav.es |
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Affiliation:
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Name:
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Ignacio Melero, MdPhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Navarra |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Cell Carcinoma
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Carcinoma, Hepatocellular
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Melanoma
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Intervention(s)
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Biological: immunotherapy with dendritic cells
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Primary Outcome(s)
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Response rate
[Time Frame: 2 months]
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Secondary Outcome(s)
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Immunological response
[Time Frame: 2 months]
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Secondary ID(s)
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CD-2007-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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