Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
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| ClinicalTrials.gov Identifier: NCT00087022 |
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Recruitment Status :
Completed
First Posted : July 12, 2004
Results First Posted : September 12, 2018
Last Update Posted : November 27, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Cancer | Biological: girentuximab Other: placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 864 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | October 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
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Biological: girentuximab
Given IV
Other Name: Rencarex®, cG250 and WX-G250 |
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Placebo Comparator: Arm II
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
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Other: placebo
Given IV |
- Disease-free Survival [ Time Frame: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years) ]Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
- Overall Survival [ Time Frame: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years) ]Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.
- Quality of Life - Global Health Status [ Time Frame: At 12 months ]Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.
- Pharmacokinetics of WX-G250 [ Time Frame: Week 8 ]Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed primary clear cell renal cell carcinoma
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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)
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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
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087022
Show 56 study locations
| Study Director: | Pia Kloepfer, MD | Heidelberg Pharma AG | |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
| Responsible Party: | Heidelberg Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00087022 |
| Obsolete Identifiers: | NCT00209183 |
| Other Study ID Numbers: |
WX-2003-07-HR WILEX-WX-2003-07-HR ( Other Identifier: WILEX ) ARISER ( Other Identifier: WILEX ) UCLA-0404015-01 ( Other Identifier: UCLA ) CDR0000372830 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2012-00491 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) |
| First Posted: | July 12, 2004 Key Record Dates |
| Results First Posted: | September 12, 2018 |
| Last Update Posted: | November 27, 2018 |
| Last Verified: | October 2018 |
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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 |
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Kidney Neoplasms Carcinoma, Renal Cell 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 |