Phase 3
Completed N=864
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Source: ClinicalTrials.gov NCT00087022 ↗Enrolled (actual)
864
Serious AEs
8.4%
Results posted
Sep 2018
Primary outcomePrimary: Disease-free Survival — 192; 197 Participants — p=0.737
◆ Published Evidence
Highly cited
141citations · ~16 / year
Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial.
Summary
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.
Linked Publications (2)
-
Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial.
-
Body Mass Index and Survival in a Prospective Randomized Trial of Localized High-Risk Renal Cell Carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
192; 197 | 0.737 |
| PRIMARY Overall Survival |
91; 90 | 1.012 |
| SECONDARY Quality of Life - Global Health Status |
71; 71 | — |
| SECONDARY Pharmacokinetics of WX-G250 |
8.7 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00087022) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.