Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer

NCT01026337 | Completed DMC

• 2 other identifiers: UPCC 03809NCI-2009-01414
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.

Conditions

Renal Cell Carcinoma; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Keywords

recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

• Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)

Secondary Outcomes (1)

• Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Study Arms (1)

Arm I

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.

Genetic: mutation analysis; Other: pharmacological study; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Drug: sunitinib malate; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Interventions

mutation analysis GENETIC

Correlative study

Arm I

pharmacological study OTHER

Correlative study

Also known as: pharmacological studies

Arm I

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE-MRI

Arm I

sunitinib malate DRUG

Given orally

Also known as: SU011248, SU11248, sunitinib, Sutent

Arm I

immunohistochemistry staining method OTHER

Correlative study

Also known as: immunohistochemistry

Arm I

laboratory biomarker analysis OTHER

Correlative study

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AJCC stage IV or locally advanced (or inoperable) renal cell carcinoma for which archival tissue is available
• No prior anti-angiogenic therapy
• Prior radiation therapy to a symptomatic site of disease is allowed
• ECOG performance status of 0, 1 or 2
• White Blood Count \>= 3,000/mm\^3
• Absolute Granulocyte Count \>= 1,500/mm\^3
• Platelet Count \>= 100,000/mm\^3
• Serum creatinine =\< 2.0 x upper limit of normal (ULN) OR serum creatinine clearance (CrCl) \>= 40 ml/min
• Total Bilirubin =\< 1.5 x ULN (\< 3.0 x ULN in the presence of Gilbert's disease)
• AST/ALT =\< 2.5 x ULN (=\< 5.0 ULN in the presence of liver metastases)
• INR =\< 1.5 and a PTT within normal limits; patients who are taking warfarin must have documentation of an INR =\< 1.5 and a PTT within normal limits prior to the initiation of anticoagulation to rule out a baseline coagulopathy
• Patient must not have pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication
• Patient must not have hypertension that cannot be controlled by medications (diastolic blood pressure \>= 100 mm Hg despite optimal medical therapy)
• Patient must not have ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade \>= 2
• Patients must not receive any other investigational agents during the period on study

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; Immunohistochemistry

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Stephen Keefe

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (1)