Clinical trial · Interventional
Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.
NCT00151645CI-TRIAL-00000257terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| activated lymphocytes | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (4)
- measure
- - Disease free survival
- measure
- - Overall survival
- measure
- - Functional and phenotypic characteristics of injected cells
- measure
- - Biological response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDBelldegrun 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. PMID 8411405
- BACKGROUNDFiglin 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. PMID 9258071
- BACKGROUNDHayakawa 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. PMID 7645136
- BACKGROUNDMathiot 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. PMID 7577091