Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery

NCT00747305 | Terminated Phase 1 DMC

• 2 other identifiers: CDR0000612590MUSC-101219
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kidney Cancer

Keywords

stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib.

  at various points throughout the study duration

• 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

  at various points throughout the study duration

Study Arms (1)

Sunitinib

EXPERIMENTAL

Sunitinib will be administered for 8 weeks prior to sugery

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

Interventions

sunitinib malate DRUG

Sunitinib

gene expression analysis GENETIC

Sunitinib

reverse transcriptase-polymerase chain reaction GENETIC

Sunitinib

western blotting GENETIC

Sunitinib

immunohistochemistry staining method OTHER

Sunitinib

laboratory biomarker analysis OTHER

Sunitinib

adjuvant therapy PROCEDURE

Sunitinib

neoadjuvant therapy PROCEDURE

Sunitinib

therapeutic conventional surgery PROCEDURE

Sunitinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Harry Drabkin: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib; Gene Expression Profiling; Reverse Transcriptase Polymerase Chain Reaction; Blotting, Western; Immunohistochemistry; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Harry A. Drabkin, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Hematology Oncology Division

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 22, 2015

Record last verified: 2015-04

Locations

US (1)