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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: |
NCT00151645 |
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Date of registration:
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08/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
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Scientific title:
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Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial. |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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36 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00151645 |
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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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France
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Contacts
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Name:
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Véronique Catros-Quemener, PharmD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Name:
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Eric Bellissant, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Name:
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François Guillé, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Rennes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged between 18 and 70 years
- Metastatic renal adenocarcinoma histologically proven
- Karnofsky performance status = 70%
- Life expectation > 3 months
- At least one target, in a non-irradiated area
- Objective response or steady-state after a treatment with cytokines
- Informed written consent
Exclusion Criteria:
- Patients presenting more than one metastatic site with one hepatic metastasis
diagnosed within the last 12 months
- White blood cells count < 2.5 G/L, Platelet count < 100 G/L
- Serum creatinine rate > 150 µmol/L
- Positive serology for : hepatitis B, hepatitis C, retrovirus
- Patient not available for a long-term follow-up
- Bellini duct tumor
- History of allograft or tumor within the five past years
- Severe cardiovascular, hepatic, renal or pulmonary troubles
- Auto-immune disease
- Severe infection
- Pregnancy or breast-feeding
- Corticotherapy
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Renal Cell Carcinoma
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Intervention(s)
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Drug: activated lymphocytes
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Primary Outcome(s)
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Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.
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Secondary Outcome(s)
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- Disease free survival
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- Functional and phenotypic characteristics of injected cells
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- Biological response
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- Overall survival
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Secondary ID(s)
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AFSSAPS 990434
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PHRC/02-06
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CIC0203/013
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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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