Kidney Cancer Clinical Trial
Official title:
Phase I/II Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A (RO 25-8310) in Previously Untreated Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients
with advanced kidney cancer.
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in
patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile
of the MTD in this patient population. III. Determine the objective response rate, time to
response, duration of response, time to progression, and survival rate in this patient
population.
OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive
pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose
escalation of PEG-IFN continues until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity. After the MTD of PEG-IFN is determined, additional patients are treated at this
dose level. These patients may continue treatment after the first 24 weeks for up to 1 year,
in the absence of disease progression. Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 months.
;
Primary Purpose: Treatment
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