Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151645
• Other study ID #: AFSSAPS 990434
• Secondary ID: PHRC/02-06CIC020
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: December 30, 2005
• Start date: December 2003
• Est. completion date: July 2005

Study information

• Verified date: December 2005
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• activated lymphocytes

Locations

Country	Name	City	State
France	Service d'Urologie - Hôpital Pontchaillou	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Mathiot C, Thiounn N, Tartour E, Flam T, Peyret C, Joyeux I, Zerbib M, Brandely M, Debré 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- Disease free survival
Secondary	- Overall survival
Secondary	- Functional and phenotypic characteristics of injected cells
Secondary	- Biological response