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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC-10807 | |||
| PFIZER-807184 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well sunitinib works when given before and after surgery in treating patients with stage IV kidney cancer.
OBJECTIVES:
OUTLINE:
Patients undergo dynamic contrast-enhanced MRI with motexafin gadolinium and positron emission tomography with iodine I 124 chimeric monoclonal antibody G250 at baseline and after completion of neoadjuvant sunitinib malate (prior to cytoreductive nephrectomy).
Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Tumor tissue samples are analyzed for VHL mutations and other somatic genetic mutations by mutation analysis; allelic loss or gain by comparative genomic amplification; microvessel density (MVD) by immunohistochemical staining for CD34 and CD105; pERK, SMA, Ki-67, HIF-1α, CAIX, macrophage migration inhibition factor (MIF), and CREB by multicolor analysis; and VEGF-R1 and -R2 and other relevant antigen expression by validated assays. Blood samples are analyzed for pharmacokinetics; angiogenic growth factor levels (e.g., free VEGF, basic FGF, and other markers); and polymorphisms in VEGF, VEGFR, VHL, and HIF.
After completion of study treatment, patients are followed periodically.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motexafin gadolinium | Drug | |||
| sunitinib malate | Drug | |||
| comparative genomic hybridization | Genetic | |||
| gene expression analysis | Genetic | |||
| mutation analysis | Genetic | |||
| polymorphism analysis | Genetic | |||
| immunohistochemistry staining method | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression as assessed by RECIST criteria |
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DISEASE CHARACTERISTICS:
Diagnosis of renal cell carcinoma
Radiographic evidence of disease for which cytoreductive nephrectomy is deemed to be clinically indicated AND for which preoperative embolization is not deemed necessary by the surgeon
No history or clinical evidence of brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
WBC ≥ 3,000/mm³
Absolute granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR serum creatinine clearance ≥ 40 mL/min
Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's disease)
AST/ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
INR ≤ 1.5*
PTT normal*
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
No hypertension that cannot be controlled by medications (i.e., diastolic BP ≥ 100 mm Hg despite optimal medical therapy)
No ongoing cardiac dysrhythmias ≥ grade 2 (according to NCI CTCAE v3.0)
No other concurrent malignancies
No concurrent serious illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Keith T. Flaherty, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104-4283 | United States |
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| iodine I-124 girentuximab | Other |
| laboratory biomarker analysis | Other |
| pharmacological study | Other |
| adjuvant therapy | Procedure |
| neoadjuvant therapy | Procedure |
| therapeutic conventional surgery | Procedure |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
| D000077210 | Sunitinib |
| D055028 | Comparative Genomic Hybridization |
| D020869 | Gene Expression Profiling |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D007150 | Immunohistochemistry |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| 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 |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D016172 | DNA Fingerprinting |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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