Renal Cell Carcinoma (RCC) Scramble
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Purpose
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 you receive as part of UT MD Anderson Cancer Center study 2010-0085 (either temsirolimus, bevacizumab, or pazopanib) is working.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Procedure: Perfusion CT scan |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085 |
- Blood Flow (BF) Reduction [ Time Frame: From 4 weeks prior to first dose to 8 weeks post treatment ] [ Designated as safety issue: No ]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.
- Progression Free Survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]PFS is calculated from the start of the study until disease progression.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DCE-CT Scans
DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
|
Procedure: Perfusion CT scan
DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
|
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 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be enrolled or being considered for enrollment on protocol 2010-0085.
- Patients must have metastatic renal cell carcinoma (RCC).
- Age >/= 18 years.
- Subjects must have adequate renal function as defined by serum creatinine < 1.5x upper limit of normal.
Exclusion Criteria:
- Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks
- Female subjects who are pregnant or lactating.
- Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment).
- Allergy to CT contrast media requiring the administration of steroid prophylaxis.
Contacts and Locations| Contact: Chaan Ng, MD | 713-792-6759 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Chaan Ng, MD | |
| Principal Investigator: | Chaan Ng, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01224288 History of Changes |
| Other Study ID Numbers: | 2009-0845 |
| Study First Received: | October 18, 2010 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
RCC Kidney cancer Metastatic renal cell carcinoma mRCC |
Dynamic contrast enhanced CT DCE-CT Tumor perfusion |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013