Back to resultsEfficacy of Activated Lymphocytes in Renal Cell Carcinoma.
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
activated lymphocytes
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Immunotherapy, Renal cell carcinoma, Metastasis, Lymphokine activated killers, Cell therapy
Eligibility 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
Sites / Locations
- Service d'Urologie - Hôpital Pontchaillou
Outcomes
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
Full Information
NCT ID
NCT00151645
First Posted
September 8, 2005
Last Updated
December 30, 2005
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00151645
Brief Title
Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
Official Title
Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Terminated
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Immunotherapy, Renal cell carcinoma, Metastasis, Lymphokine activated killers, Cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
activated lymphocytes
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
- Disease free survival
Title
- Overall survival
Title
- Functional and phenotypic characteristics of injected cells
Title
- Biological response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Catros-Quemener, PharmD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
François Guillé, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Urologie - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
8411405
Citation
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.
Results Reference
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PubMed Identifier
9258071
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. doi: 10.1097/00005392-199709000-00012.
Results Reference
background
PubMed Identifier
7645136
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. doi: 10.1159/000282651.
Results Reference
background
PubMed Identifier
7577091
Citation
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.
Results Reference
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Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
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