A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing
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/m^2
cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be
administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6
ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles. This
is the first time that ZYC300 and Cyclophosphamide will be given together. Cyclophosphamide
is a chemotherapy drug approved by the FDA that has been used for many years in many
different kinds of cancer. In this trial the study drug will be used to boost the immune
system. Sometimes the immune system cannot fight infected or abnormal cells because of
other cells called T reg cells. The T reg cells limit the immune systems attack on infected
or abnormal cells. In this study, the hope is that Cyclophosphamide will inhibit the T regs
cells so that the ZYC300 can work better to attack the cancer cells.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the feasibility, safety and tolerability of administering ZYC300 intramuscularly every other wk for 6 doses (400 micrograms DNA/total dose) to the study pop. pre-dosed with 600 mg/m^2 cyclophosphamide intravenously 3 days prior to study drug.
Within 14 days and 12 weeks post last dose of study drug (and 16 weeks post last dose for response confirmation, if applicable).
Michael Silverman, MD
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|M. D. Anderson Cancer Center||Houston, Texas 77030|