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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01414 |
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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.
Primary Objectives:
I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).
II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.
Secondary Objectives:
I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.
II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters.
Outline: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mutation analysis | Genetic | Correlative study |
| |
| pharmacological study |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria |
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Keefe | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Other |
Correlative study |
|
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| dynamic contrast-enhanced magnetic resonance imaging | Procedure | Undergo DCE-MRI |
|
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| sunitinib malate | Drug | Given orally |
|
|
| immunohistochemistry staining method | Other | Correlative study |
|
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| laboratory biomarker analysis | Other | Correlative study |
|
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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