A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing
|Breast Cancer Ovarian Cancer Prostate Cancer Colon Cancer Renal Cancer||Drug: Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing|
- 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. [ Time Frame: Within 14 days and 12 weeks post last dose of study drug (and 16 weeks post last dose for response confirmation, if applicable). ]
- Assess the effect of cyclophosphamide on T reg number and function. Assess the generation of CYP1B1-specific immun. as a result of vac. regimen. Assess the effect of vac. regimen on tumor response, if any, in pat. pop. [ Time Frame: Within the first 14 days and at each subsequent visit. ]
|Study Start Date:||November 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Drug: Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)
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 cycles).
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 cycles).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381173
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Michael Silverman, MD||Eisai Inc.|