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Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

NCT ID: NCT00151645

Last Updated: 2006-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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activated lymphocytes

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Véronique Catros-Quemener, PharmD, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

CHU Rennes

François Guillé, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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Service d'Urologie - Hôpital Pontchaillou

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 8411405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9258071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7645136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7577091 (View on PubMed)

Other Identifiers

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PHRC/02-06

Identifier Type: -

Identifier Source: secondary_id

CIC0203/013

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 990434

Identifier Type: -

Identifier Source: org_study_id