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A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)


OBJECTIVES:

Primary

- Evaluate the disease-free and overall survival of patients with primary clear cell
renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal
antibody cG250 (WX-G250) vs placebo in an adjuvant setting.

Secondary

- Evaluate the safety of these drugs in these patients.

- Assess the quality of life of patients treated with this drug.

- Perform pharmacokinetic analysis of WX-G250.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to risk criteria and participating centers (US vs Non-US). Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes
once weekly for 24 weeks.

- Arm II: Patients receive placebo IV over 15 minutes once weekly for 24 weeks. In both
arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Blood samples are collected for pharmacokinetic analysis.

Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6
months after completion of study treatment.

Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and
4, and then annually during year 5 and thereafter.

PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm)
were accrued for this trial.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary clear cell renal cell carcinoma

- Meets 1 of the following high risk criteria:

- T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0

- Any T stage and N + disease and M0

- T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other
nuclear grading system with at least 3 grades)

- Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented
clear cell histology within the past 12 weeks

- No evidence of macroscopic or microscopic residual disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Platelet count > 100,000/mm^3

- WBC > 3,000/mm^3

- Hemoglobin > 10 g/dL

Hepatic

- AST and ALT < 3 times upper limit of normal (ULN)

- Bilirubin < 1.5 times ULN

- Hepatitis B surface antigen (HbsAg) negative

- Hepatitis C antibody negative

Renal

- Creatinine < 2.0 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV I and II negative

- No concurrent unrelated illness which can significantly jeopardize patients' clinical
status

- No active infection

- No inflammation

- No medical condition or laboratory abnormalities that would preclude study
participation

- No other malignancies within the past 5 years except surgically cured nonmelanoma
skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 5 years since prior immunotherapy

- No prior murine or chimeric antibody therapy

Chemotherapy

- More than 5 years since prior chemotherapy

Endocrine therapy

- No concurrent corticosteroids above Cushing dose for another disease

- Physiologic corticosteroid replacement therapy allowed at discretion of the
primary investigator

Radiotherapy

- More than 5 years since prior radiotherapy

Surgery

- See Disease Characteristics

- No prior organ transplantation

Other

- No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

Local 360 DFS events

Safety Issue:

No

Principal Investigator

Pia Kloepfer, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wilex

Authority:

United States: Food and Drug Administration

Study ID:

WX-2003-07-HR

NCT ID:

NCT00087022

Start Date:

July 2004

Completion Date:

October 2012

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage I renal cell cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mount Sinai School of MedicineNew York, New York  10029
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Augusta Oncology Associates - Walton WayAugusta, Georgia  30901
Anchorage, Alaska  
AccuMed Research AssociatesGarden City, New York  11530
Urology AssociatesNashville, Tennessee  37209
Nevada Cancer InstituteLas Vegas, Nevada  89135
University of CincinnatiCincinnati, Ohio  45267-0502
Helen F. Graham Cancer Center at Christiana HospitalNewark, Delaware  19718
Atlantic Urological Associates - Daytona BeachDaytona Beach, Florida  32114
Southeastern Research GroupTallahassee, Florida  32308
North Idaho Urology - Coeur d'AleneCoeur d'Alene, Idaho  83814-2668
Northeast Indiana Urology, PCFort Wayne, Indiana  46804
Hematology and Oncology Specialists, LLC - MetairieMetairie, Louisiana  70006
Regional Urology, LLCShreveport, Louisiana  71106
Werner-Francis Urology Associates, LLCGreenbelt, Maryland  20770
Community Care Physicians, PC at Urological Institute of NENYAlbany, New York  12209
Hudson Valley Urology, PCPoughkeepsie, New York  12601
Alliance Urology Specialists - GreensboroGreensboro, North Carolina  27403
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Urological Associates of Lancaster, LimitedLancaster, Pennsylvania  17604
Mary Crowley Medical Research Center at Sammons Cancer CenterDallas, Texas  75246
Urology Associates of South Texas, PAMcAllen, Texas  78503
Urology San Antonio, PA - FredericksburgSan Antonio, Texas  78229