Back to results

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

Primary Purpose

Kidney Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

sunitinib malate

gene expression analysis

reverse transcriptase-polymerase chain reaction

western blotting

immunohistochemistry staining method

laboratory biomarker analysis

adjuvant therapy

neoadjuvant therapy

therapeutic conventional surgery

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hollings Cancer Center at Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

Sunitinib will be administered for 8 weeks prior to sugery

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00747305

First Posted

September 4, 2008

Last Updated

October 21, 2015

Sponsor

Harry Drabkin

1. Study Identification

Unique Protocol Identification Number

NCT00747305

Brief Title

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

Official Title

Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Study terminated early due to low accrual.

Study Start Date

October 2008 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Harry Drabkin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in kidney cancer specimens from patients with metastatic renal cell carcinoma treated with sunitinib malate. To describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by response, duration of response, and time to progression in these patients. OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off study with other agents. Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of circulating levels of VEGF and selected chemokines. After completion of study therapy, patients are followed monthly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Experimental

Arm Description

Sunitinib will be administered for 8 weeks prior to sugery

Intervention Type

Drug

Intervention Name(s)

sunitinib malate

Intervention Type

Genetic

Intervention Name(s)

gene expression analysis

Intervention Type

Genetic

Intervention Name(s)

reverse transcriptase-polymerase chain reaction

Intervention Type

Genetic

Intervention Name(s)

western blotting

Intervention Type

Other

Intervention Name(s)

immunohistochemistry staining method

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Primary Outcome Measure Information:

Title

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

Time Frame

at various points throughout the study duration

Title

Time Frame

at various points throughout the study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry A. Drabkin, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hollings Cancer Center at Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs