Group (A) [study cases] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.

Group (B) [control cases] Adult patients who will undergo simple nephrectomy for benign causes

Renal Cell Carcinoma

Histopathological study and evaluation:
For each case, the tissue samples will be evaluated by the pathologist for detecting the histopathology and in cases of malignant renal spicemens the pathologist will also assess the histologic type, Fuhrman nuclear grade, cellular invasion of perinephric fat, and the extent of any vascular invasion seen by microscopy.
Immunohistochemistry:
Immunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2).
Evaluation of the immunohistochemical staining will be performed by light microscopy. The interpretation of immuno-reactivity will be performed in a quantitative manner by analyzing the extent of the staining positivity of the tumor cells. Immuno-staining of greater than 10% of tumor cells is required for scoring as a positive case.

Immunohistochemistry

Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

Role of Immunohistochemical Markers , Geminin and Mcm2 in Prognosis of Renal Cell Carcinoma, and Its Clinicopathological Correlation. A Prospective Controlled Study

Number of patients that develops recurrent tumor after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

Number of patients that develops tumor metastasis after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

Mohamed Abdelghany Allam

Assistant lecturer

Assiut University

2 groups : Group A include cases and Group B includes controls

Renal Neoplasm With Metastasis

Response Evaluation Criteria in Solid Tumors

Aarhus University Hospital

Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT

Response Evaluation Criteria in Metastatic Renal Cell Carcinoma: Improved Assessment of Response and Progression by Spectral-CT

PFS is the time from the initiation of therapy and until progressive disease or death, whichever comes first, assessed up to 60 months. If a patient does not progress, PFS will be censored at the time of last follow-up - assessed up to 60 months.

Overall survival is the time between the first day of treatment and the date of death or last follow-up - assessed up to 60 months.

Response will be categorized according to the criteria from RECIST 1.1: complete response, partial response, stable disease and progressive disease - assessed up to 60 months.

Frede Donskov

Consultant, Associate Professor

University of Aarhus

Phase I: Patients receive sorafenib PO twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sorafenib and bevacizumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Phase II: Patients receive sorafenib PO once daily on days 1-28 and bevacizumab IV over 90 minutes on days 1 and 15 at the MTD in the absence of disease progression or unacceptable toxicity.

Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.

Phase I

Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.

Phase II

Total

Sex: Female, Male

Region of Enrollment

The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.

Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.

Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)

Months from date on-study to expired or last date known alive

The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.

Overall Survival

Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.

Progression-free Survival

The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.

Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)

Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive

The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.

Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.

Objective Response

Overall Study

Jeffrey Sosman, MD

Chromophobe Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Papillary Renal Cell Carcinoma

Recurrent Renal Cell Carcinoma

Sarcomatoid Renal Cell Carcinoma

Stage IV Renal Cell Cancer

Bevacizumab

Sorafenib Tosylate

Pharmacological Study

Laboratory Biomarker Analysis

Dana-Farber Cancer Institute

Dana-Farber Harvard Cancer Center

Beth Israel Deaconess Medical Center

University of Pennsylvania/Abramson Cancer Center

Vanderbilt-Ingram Cancer Center

Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

A Phase I/II Trial of BAY 43-9006 in Combination With Bevacizumab in Patients With Advanced Renal Cancer

National Cancer Institute (NCI)

TroVax: Intramuscular into the deltoid muscle of the upper arm, 10x dose (6.83 x 108 pfu/ml). IL 2: High dose IL 2, 600,000 IU/kg intravenously every 8 hours up to a maximum of 15 injections.

Carcinoma, Renal Cell

TroVax

Interleukin-2

Columbia Presbyterian Medical Center

A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer

Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction With Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer

incidence of adverse events, laboratory tests and occurrence of dose limiting toxicity

kidney neoplasms/phosphatase

Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT

Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer

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