Renal Cell Carcinoma
Conditions
Keywords
RCC, Kidney cancer, Metastatic renal cell carcinoma, mRCC, Dynamic contrast enhanced CT, DCE-CT, Tumor perfusion
Brief summary
This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy in Advanced Renal Cell Carcinoma Therapy: The START Trial). The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.
Detailed description
To perform a DCE-CT scan, a small amount of a special dye (called CT contrast medium) is injected by vein into the body. Several CT images are then taken over a few minutes to learn how much dye spreads outside of the tumor. This can show how much blood flows to and from the tumor. By performing DCE-CT scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working. Study Procedures: If you are found to be eligible to take part in this study, you will have a DCE-CT scan to check the status of the disease at the following times: * Within about 4 weeks before you begin treatment on study 2010-0085. * Eight (8) weeks after starting treatment on study 2010-0085. Before each of the DCE-CT scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function. If your doctor thinks it is needed, you will also have a standard-of-care CT scan at these timepoints to check the status of the disease. Length of Study: Your participation in this study will be over after the scan(s) 8 weeks after starting treatment on study 2010-0085. You will be taken off of this study if you leave the 2010-0085 study early. This is an investigational study. The DCE-CT scan is commercially available. Using DCE-CT scans to check the status of kidney cancer is investigational. Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
Interventions
PROCEDUREPerfusion CT scan
DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must be enrolled or being considered for enrollment on protocol 2010-0085. 2. Patients must have metastatic renal cell carcinoma (RCC). 3. Age \>/= 18 years. 4. Subjects must have adequate renal function as defined by serum creatinine \< 1.5x upper limit of normal.
Exclusion criteria
1. Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks 2. Female subjects who are pregnant or lactating. 3. Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment). 4. Allergy to CT contrast media requiring the administration of steroid prophylaxis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Blood Flow (BF) Reduction | From 4 weeks prior to first dose to 8 weeks post treatment | Changes in perfusion parameters assessed at first re-staging (approximately 8 weeks) and shortly after initiating therapy (2 - 7 days), for three different therapies using organ-directed DCE-CT tumor assessments. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 3 years | PFS is calculated from the start of the study until disease progression. |
Countries
United States
Outcome results
None listed