Kidney Cancer Clinical Trial
Official title:
A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in
treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory
to treatment with interleukin-2 or unable to be treated with interleukin-2.
OBJECTIVES:
- Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal
antibody in patients with metastatic clear cell renal cancer who are refractory to or
ineligible for interleukin-2.
- Determine the impact of this drug on T-cell number and phenotype in these patients.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV
over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression
or unacceptable toxicity. Patients with an ongoing partial response may receive additional
courses of therapy.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and
then annually until disease progression.
PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4
years.
;
Masking: Open Label, Primary Purpose: Treatment
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