Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-Metastatic Kidney Cancer - Full Text View

Sponsored by:	Wilex
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00087022

Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.

Condition	Intervention	Phase
Kidney Cancer	Drug: monoclonal antibody G250 Procedure: adjuvant therapy	Phase III

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Immunoglobulins Globulin, Immune Rencarex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival every 3 months for 2 years, 6 months for 2 years and then at 1 year [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life by EORTC Quality of Life Questionnaire-C30 at 3, 6, and 12 months [ Designated as safety issue: No ]
Safety by NCI CTCAE v3.0 at 1 month following study treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:	856
Study Start Date:	July 2004
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Detailed Description:

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.

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.

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: Approximately 856 patients (428 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087022

Show 56 Study Locations

Sponsors and Collaborators

Wilex

Investigators

Study Chair:	Pia Kloepfer, MD	Wilex
Investigator:	Arie Belldegrun, MD, FACS	Jonsson Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Wilex AG ( Norman Neville )
Study ID Numbers:	CDR0000372830, WILEX-WX-2003-07-HR, OLMMC-04019, ARISER, UCLA-0404015-01
Study First Received:	July 8, 2004
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00087022
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Antibodies, Monoclonal
Antibodies
Urologic Diseases

Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Clear cell renal cell carcinoma
Urinary tract neoplasm
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009