Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: girentuximab; placebo
Intervention description: Given IV; Given IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 864.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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

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.
    

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)