Clinical trial · Interventional
Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer
A Histopathologic and Imaging Study of Renal Cell Carcinoma Vasculature in the Setting of Sunitinib Therapy Prior to Cytoreductive Nephrectomy
- 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: 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| comparative genomic hybridization | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| iodine I-124 girentuximab | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (1)
- measure
- Tumor regression as assessed by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of renal cell carcinoma * AJCC stage IV disease * 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: * Ongoing or active infection requiring parenteral antibiotics * Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina) * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ grade 2 within the past year * Psychiatric illness/social situation that would limit compliance with study requirements NOTE: \*Patients who are taking warfarin must have documentation of an INR ≤ 1.5 and PTT normal prior to the initiation of anticoagulation to rule out a baseline coagulopathy PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior radiotherapy and recovered * Prior radiotherapy to a symptomatic site of metastatic disease is allowed * No prior systemic therapy * No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) * No other concurrent investigational agents
References
Publications (0)
Data not yet available