Clinical trial · Interventional
Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery
Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated early due to low accrual.
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 clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- Sunitinib will be administered for 8 weeks prior to sugery
- interventionNames
- Drug: sunitinib malate
- Genetic: gene expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Genetic: western blotting
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: adjuvant therapy
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
- measure
- Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib.
- timeFrame
- at various points throughout the study duration
- measure
- Describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors with the clinical efficacy of Sunitinib as measured by response, duration or response and time to progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of clear cell renal cell carcinoma * Metastatic disease * Primary tumor is considered amenable to surgery * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as \> 20 mm by conventional techniques or as \> 10 mm by spiral CT scan * No untreated brain metastases * Treated brain metastases allowed provided lesion has been stable on two consecutive CT or MRI scans separated by ≥ 2 months PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Leukocytes ≥ 3,000/μL * ANC ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Hemoglobin ≥ 8.5 g/dL * Total Bilirubin ≤ 2 times upper limits of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to undergo nephrectomy and treatment with sunitinib malate * No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior systemic treatment with sunitinib malate * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * Concurrent medications or substances known to affect, or with the potential to affect, the activity or pharmacokinetics of sunitinib malate allowed at the discretion of the principal investigator
References
Publications (0)
Data not yet available