- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151645
Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
December 30, 2005 updated by: Rennes University Hospital
Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.
Renal cell carcinoma represents today 3% of the solid tumors of the adult.
Their bad prognosis is due to the frequency of metastasis and the resistance to chemotherapy.
Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important toxicity.
In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Phase I and II trials for the treatment of melanoma or renal cell carcinoma have already evaluated lymphokine-activated killer cells and tumor-infiltrating cells.
In metastatic renal cell carcinoma, these therapies have shown some complete responses and a low toxicity.
In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.
A secondary objective is to improve cell preparation methods and to characterize functionally and phenotypically injected cells.
Study Type
Interventional
Enrollment
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rennes, France, 35033
- Service d'Urologie - Hôpital Pontchaillou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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 Measures
Outcome Measure |
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- Disease free survival
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- Overall survival
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- Functional and phenotypic characteristics of injected cells
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- Biological response
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Véronique Catros-Quemener, PharmD, PhD, CHU Rennes
- Principal Investigator: François Guillé, MD, CHU Rennes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Belldegrun A, Pierce W, Kaboo R, Tso CL, Shau H, Turcillo P, Moldawer N, Golub S, deKernion J, Figlin R. Interferon-alpha primed tumor-infiltrating lymphocytes combined with interleukin-2 and interferon-alpha as therapy for metastatic renal cell carcinoma. J Urol. 1993 Nov;150(5 Pt 1):1384-90. doi: 10.1016/s0022-5347(17)35785-3.
- Figlin RA, Pierce WC, Kaboo R, Tso CL, Moldawer N, Gitlitz B, deKernion J, Belldegrun A. Treatment of metastatic renal cell carcinoma with nephrectomy, interleukin-2 and cytokine-primed or CD8(+) selected tumor infiltrating lymphocytes from primary tumor. J Urol. 1997 Sep;158(3 Pt 1):740-5. doi: 10.1097/00005392-199709000-00012.
- Hayakawa M, Hatano T, Ogawa Y, Gakiya M, Ogura H, Osawa A. Treatment of advanced renal cell carcinoma using regional arterial administration of lymphokine-activated killer cells in combination with low doses of rIL-2. Urol Int. 1994;53(3):117-24. doi: 10.1159/000282651.
- Mathiot C, Thiounn N, Tartour E, Flam T, Peyret C, Joyeux I, Zerbib M, Brandely M, Debre B, Fridman WH. Non-cytotoxic CD4 tumour-infiltrating lymphocytes induce responses in patients with metastatic renal cell carcinoma previously treated with interleukin-2. Eur J Cancer. 1995;31A(9):1551-2. doi: 10.1016/0959-8049(95)00235-b. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Estimate)
January 2, 2006
Last Update Submitted That Met QC Criteria
December 30, 2005
Last Verified
December 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFSSAPS 990434
- PHRC/02-06
- CIC0203/013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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