Phase I/II Open Label Multi-Center Study of CPG 7909 in Patients With Stage IV Renal Cell Cancer
In the Phase I portion of the trial, escalating doses CPG 7909 injection will be administered
subcutaneously up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell
cancer. The maximum tolerated dose for CPG 7909 injection as monotherapy will be determined.
In the phase II portion of the trial, the overall tumor response rate of CPG 7909 will be
estimated according to the RECIST criteria in patients with metastatic renal cell cancer.
Tolerability will be assessed according to dose exposure, immunologic activity, the
pharmacokinetic and pharmacodynamic profile of CPG 7909 injection, time to progression,
duration of response, and time to survival.
Study Status: Completed
Renal Cell Cancer
Drug: CPG 7909
Phase 1/Phase 2
Information provided by:
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Cleveland Clinic Cancer Center
Cleveland, Ohio 44195