Efficacy of Activated Lymphocytes in Renal Cell Carcinoma. - Full Text View

Sponsors and Collaborators:	Rennes University Hospital Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00151645

Purpose

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.

Condition	Intervention	Phase
Metastatic Renal Cell Carcinoma	Drug: activated lymphocytes	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.

Secondary Outcome Measures:

- Disease free survival
- Overall survival
- Functional and phenotypic characteristics of injected cells
- Biological response

Estimated Enrollment:	36
Study Start Date:	December 2003
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151645

Locations

France
Service d'Urologie - Hôpital Pontchaillou
Rennes, France, 35033

Sponsors and Collaborators

Rennes University Hospital

Ministry of Health, France

Investigators

Study Director:	Véronique Catros-Quemener, PharmD, PhD	CHU Rennes
Study Chair:	Eric Bellissant, MD, PhD	CHU Rennes
Principal Investigator:	François Guillé, MD	CHU Rennes

More Information

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.

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.

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.

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. No abstract available.

Study ID Numbers:	AFSSAPS 990434, PHRC/02-06, CIC0203/013
Study First Received:	September 8, 2005
Last Updated:	December 30, 2005
ClinicalTrials.gov Identifier:	NCT00151645
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

Immunotherapy
Renal cell carcinoma
Metastasis
Lymphokine activated killers
Cell therapy

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Neoplasm Metastasis
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009