Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2009-0845


NCT ID:

NCT01224288


Secondary ID:

NCI-2011-03288


Study Acronym:


Brief Title:

Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Th


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Chaan Ng, MD
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:January 2011
Completion Date:January 2021
Completion Type:Anticipated
Primary Completion Date:January 2020
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 9, 2019
First Received Date:October 18, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Tumor Blood Flow (BF) Reduction
Time Frame:From 4 weeks prior to first dose to 8 weeks post treatment
Safety Issues:False
Description: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 c
Outcome Type:Secondary Outcome
Measure:Progression Free Survival (PFS)
Time Frame:3 years
Safety Issues:False
Description:PFS is calculated from the start of the study until disease progression.

Study Interventions

Intervention Type:Procedure
Name:Perfusion CT scan
Description:DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
Arm Name:DCE-CT Scans

Study Arms

Study Arm Type:Experimental
Arm Name:DCE-CT Scans
Description:DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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