Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01224288
First received: October 18, 2010
Last updated: October 5, 2015
Last verified: October 2015

October 18, 2010
October 5, 2015
January 2011
January 2017   (final data collection date for primary outcome measure)
Tumor 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. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans.
Blood Flow (BF) Reduction and Progression Free Survival (PFS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01224288 on ClinicalTrials.gov Archive Site
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.
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Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Cell Carcinoma
Procedure: Perfusion CT scan
DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
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.
Intervention: Procedure: Perfusion CT scan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
January 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224288
2009-0845, NCI-2011-03288
No
Not Provided
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Chaan Ng, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP