ERX - A thread for everyone

Further study details as provided by MGI Pharma:Primary Outcomes: Determine the feasibility, safety & tolerability of administering ZYC300 intramuscularly every other wk for 6 doses (400 g DNA/total dose) to the study pop. pre-dosed with 600 mg/m2 cyclophosphamide given intravenously 3 days prior to study drug.
Secondary Outcomes: Assess the effect of cyclophosphamide on Treg number & function.; Assess the generation of CYP1B1-specific immunity as a result of this vaccination regimen.; Assess the effect of this vaccination regimen on tumor response if any in this pt pop.
Expected Total Enrollment: 20 Study start: September 2006; Expected completion: April 2007
Last follow-up: April 2007; Data entry closure: April 2007
This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies (cancerous growths) of the ovary, breast, colon, or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy. Patients who meet all entry criteria will be administered 600 mg/m2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 g DNA/total dose every two weeks for a maximum of six doses (6 cycles).