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Status:

COMPLETED

Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer

Lead Sponsor:

Heidelberg Pharma AG

Conditions:

Kidney Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE3

Brief 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 t...

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 cG...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2012

    Estimated Enrollment :

    864 Patients enrolled

    Trial Details

    Trial ID

    NCT00087022

    Start Date

    July 1 2004

    End Date

    October 1 2012

    Last Update

    November 27 2018

    Active Locations (56)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (56 locations)

    1

    Anchorage, Alaska, United States, 99508

    2

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    3

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    4

    Helen F. Graham Cancer Center at Christiana Hospital

    Newark, Delaware, United States, 19718