An interventional study of Sunitinib, Pazopanib, Bevacizumab, Everolimus... in Renal Cell Carcinoma, sponsored by Heidelberg University. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-04.
Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment
Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Within surgery remaining tumor tissue will be used for the scientific analysis. In case of disease progression during the drug treatment the drug therapy will be changed. Before therapy change a small tissue sample will be collected for molecular diagnostics. This will be done by puncture through the skin under local anesthesia. Blood samples taken before surgery and at the time of first and second disease progression will also be used for molecular-biological analysis. As there is no clear recommendation for drug therapy after disease progression this study should serve to determine an individual therapy on the basis of the molecular profile and the molecular changes. As the tumor disease changes and developes resistance to drugs, analysis at the time of disease progression shall identify biological factors which will predict a likelihood response to a specific drugs.
This shall allow to give the patient an individual therapy.
Aim of this study is to perform a profound molecular analysis of the tumor before beginning therapy and after failure of the approved targeted first-and second line therapy (standard therapy). The tumor sample will be analyzed by using profound molecular analysis to identify target structures which will predict the efficacy of a specific therapy (substance group)and therefore have a predictive value. The analysis of molecular biomarkers include the genomic sequencing of targeted areas or of the entire DNA of the tumor tissue comparative to the DNA of healthy cells, the measurement of DNA-regulatory elements (methylation, mi-RNA expression, protein expression analytics, functional tumorcell analysis in-vitro, efficacy analysis in cell culture or in animal model) who are supposed to inspect the biological influence of the molecular biomarkers and measurements of free tumor DNA out of the blood.
The response to the established standard therapy in the first and second line will be acquired due to all clinical and radiological established standard parameters. The clinical-radiological response will be correlated with the molecular changes and their changes in therapy process to allow predictive prognosis for a further therapy.
There is no approved clinical standard for third line therapy. However there are further medications approved without any scientific evidence of their efficacy in this therapy situation (third line treatment after failure of first and second line treatment) and for which a response of under 6 weeks is expected.
For these patients the third line therapy will be adjusted to the molecular profiles of the previous therapies. Therefore the oncological history of the noticed marker profiles and the presence of target structures (from whom it is known that they are influenced by certain substances) will be considered.
The therapy will use substances which are approved in general for the treatment of metastatic renal cell cancer.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 4 is below the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Minimum Age: 18 Years Maximum Age: no maximum age
Exclusion Criteria:
Guidelines-oriented therapy with approved systemic medications for renal cell carcinoma individually for each patient (Receptor-Tyrosinkinase-Inhibitor) (e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus, Axitinib, Temsirolimus). With 1.progression turning to second line treatment with one of the upper mentioned medications. Third line therapy due to the individual molecular modifications for each patient.
Drug: Sunitinib, Pazopanib, Bevacizumab, Everolimus...
Clinical standard
Also known as: e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus...
Time to disease progression in third line therapy
Progression free survival in third-line therapy ( defined as the time from beginning of the third-line therapy to the date of the first documented progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors criteria assessed by CT/MRI every 12 weeks).
Time frame: Approximately 2 years depending on when the failure in third line therapy happens
Identification of preventive biomarkers.
Identification of preventive biomarkers.
Time frame: 2weeks in average before surgery and 4 weeks in average after surgery before starting first line treatment
Identification of preventive biomarkers
Time frame: 2years
This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.