Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma
Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved
impressive clinical results with durable complete responses in patients with metastatic
melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion
and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
Interleukin-2 is administered to support T cell activation and proliferation in vivo.
Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,
including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with
metastatic Renal Cell Carcinoma.
Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved
impressive clinical results with durable complete responses in patients with metastatic
melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion
and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
Interleukin-2 is administered to support T cell activation and proliferation in vivo.
Objectives:
To evaluate safety and feasibility when treating patients with metastatic renal cell
carcinoma with ACT with TILs.
To evaluate treatment related immune responses . To evaluate clinical efficacy.
Design:
Patients will be screened with a physical exam, medical history, blood samples, pulmonary
function test, Cr-EDTA clearance, MUGA scan and ECG.
Patients will undergo surgery to harvest tumor material for TIL production.
Patients is admitted day -8 in order to undergo lymphodepleting chemotherapy with
cyclophosphamide and fludara starting day -7.
On day 0 patients receive TIL infusion and shortly after starts IL-2 administration with
high-dose bolus IL-2 every eight hour for up to 5 days (maximum of 15 doses).
The patients will followed until progression or up to 5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00930033 -
Clinical Trial to Assess the Importance of Nephrectomy
|
Phase 3 | |
| Recruiting |
NCT05863351 -
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
|
Phase 3 | |
| Not yet recruiting |
NCT06284564 -
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
|
Phase 2 | |
| Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
| Active, not recruiting |
NCT03149822 -
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03647878 -
Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
|
||
| Completed |
NCT01517243 -
Phase II Study of Alternating Sunitinib and Temsirolimus
|
Phase 2 | |
| Withdrawn |
NCT03927248 -
PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT02122003 -
Second Line Sorafenib After Pazopanib in Patients With RCC
|
Phase 2 | |
| Completed |
NCT01182142 -
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
|
Phase 2 | |
| Completed |
NCT00630409 -
Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
| Completed |
NCT04076787 -
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
|
||
| Active, not recruiting |
NCT04467021 -
Cancer and Blood Pressure Management, CARISMA Study
|
N/A | |
| Recruiting |
NCT05119335 -
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02282579 -
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
|
||
| Completed |
NCT01731158 -
Sequential Therapy in Metastatic Renal Cell Carinoma
|
Phase 2 | |
| Terminated |
NCT02071641 -
Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT01342627 -
Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT01274273 -
Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer
|
Phase 2 |