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Study Summary
No. 2004-0274:.......Kidney......Eric Jonasch......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
2004-0274
Study Title:Dynamic Contrast Enhancement Computed Tomography in Patients with Metastatic Renal Cell Carcinoma Receiving Targeted Therapy (Companion to Protocol 2003-0982 and 2004-0516).
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Physician New Patient Referral
Name:Eric JonaschPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:N/A
Phase of Study:N/AReturn
Visit:
Approximately 2 additional visits (2 of 3 scans occur in conjunction with
standard of care scans, if possible).
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out if blood flow
measurements to tumors can be repeated identically using Dynamic
contrast-enhanced (dce) CT scans. Researchers also want to see how treatment
with Avastin and BAY43-9006 will affect tumor blood flow in your kidney tumor.
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Study Objectives / Outcomes
Primary Objectives:

1. To determine the change in perfusion parameters derived from dceCT, in patients with metastatic renal cell carcinoma undergoing therapy with targeted therapy, shortly after initiation of therapy, and at subsequent time points in the primary tumor.
2. To assess the reproducibility of perfusion parameters as derived from dceCT, in the evaluation of primary renal tumors.

Secondary Objectives:

1. To compare serial changes in dceCT measurements with changes in serum VEGF and bFGF levels.
2. To compare changes in dceCT measurements with changes in levels of phospho VEGFR, phospho PDGFR, phospho EGFR and microvessel density in resected tumors.
3. To compare the changes in functional measures with conventional radiographic assessments.
4. To compare the changes in functional measures with time to progression.
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Study Status Information
Study Activation / Registration Date:04/27/2005
IRB Review and Approval Date:01/19/2005
Study Type:Not Applicable
Recruitment Status:Terminated
Projected Accrual:36
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must have metastatic RCC, have a primary lesion in place, are being considered for presurgical systemic therapy.

2) Subjects must have an ECOG performance score of 0-2.

3) Subjects must have adequate renal function as defined by serum creatinine </=1.5 mg/dL or a calculated creatinine clearance of 60 ml/min.

4) Eligible subjects must have a primary tumor in place.

5) Patients must have at least one lesion located in the kidney. The index lesion should demonstrate visible contrast enhancement on the most recent CT or MRI scan (i.e. not cysts).

6) When there are multiple lesions, one lesion should be chosen as the index lesion. Other tumors in the scan volume should be considered of lesser importance.

7) The index lesion should be the most enhancing tumor which meets all other criteria.

8) The imaging acquisition volume should be centered on the index lesion.

9) When possible, the index lesion should be fully encompassed by the imaging acquisition volume.

10) Index lesions should be chosen to avoid motion and beam hardening artifact, particularly from vascular structures, extending into the tumor.

11) The volume of interest defined in the baseline study should be used for subsequent studies.

12) The Principal Investigator or co-Principal Investigators will have discretion to select as index lesion, the lesion which most closely match the selection criteria.

Exclusion Criteria:1) Prior/Concurrent Cancer Therapy, other than study drug.

2) Radiotherapy: Subjects may not have received prior radiotherapy.

3) Surgery: Subjects must not have received surgery for at least 30 days prior to day 1 on this study, unless pre-approved by the Principal or Sub-Investigator.

4) Female subjects who are pregnant or lactating.

5) Female subjects of childbearing potential unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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