Clinical trial · Observational
Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer
An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
NCT01026337CI-TRIAL-00039195completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage III Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Arm I
- description
- 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.
- interventionNames
- Genetic: mutation analysis
- Other: pharmacological study
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
- Drug: sunitinib malate
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Progression-free survival
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * 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 * Patients must not have a history or clinical evidence of brain metastasis; however, patients with resected or radiated brain metastases are eligible * Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication * Patients must not have a serious intercurrent illness including, but not limited to, grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort * Women must not be pregnant or breast-feeding * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation
References
Publications (0)
Data not yet available
No reference posted for this study.