Renal Cell Carcinoma (RCC) Scramble

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01224288
First received: October 18, 2010
Last updated: September 11, 2014
Last verified: September 2014
  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 study 2010-0085 (either everolimus, 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: 120
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 120 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224288

Contacts
Contact: Chaan Ng, MD 713-792-6759

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Chaan Ng, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Chaan Ng, MD M.D. 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, NCI-2011-03288
Study First Received: October 18, 2010
Last Updated: September 11, 2014
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
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014