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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC/02-06 | |||
| CIC0203/013 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated lymphocytes | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines. |
| Measure | Description | Time Frame |
|---|---|---|
| - Disease free survival | ||
| - Overall survival | ||
| - Functional and phenotypic characteristics of injected cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Véronique Catros-Quemener, PharmD, PhD | Rennes University Hospital | Study Director |
| Eric Bellissant, MD, PhD | Rennes University Hospital | Study Chair |
| François Guillé, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Urologie - Hôpital Pontchaillou | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8411405 | Background | 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. | |
| 9258071 |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000728065 | CD83 protein, human |
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| - Biological response |
| 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. |
| 7645136 | Background | 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. |
| 7577091 | Background | 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. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |