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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00381173 |
Purpose
The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Ovarian Cancer Prostate Cancer Colon Cancer Renal Cancer |
Drug: Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 22 |
| Study Start Date: | November 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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).
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in the study, patients must meet the following criteria:
Patients with:
Advanced stage malignancies who have failed treatment, including at least one, but no more than two, prior regimens of chemotherapy: Ovary, Breast, Colon, Hormone Refractory Prostate Cancer (HRPC), and renal.
Adequate hematological function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
Adequate hepatic function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
Exclusion Criteria:
Patients cannot participate in the study if any of the following apply:
Have received any of the following within 28 days prior to receiving the first dose of cyclophosphamide:
Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate.
Contacts and Locations| 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. |
More Information
| Responsible Party: | Eisai Medical Services, Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00381173 History of Changes |
| Other Study ID Numbers: | ZYC3-002 |
| Study First Received: | September 26, 2006 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
MGI PHARMA ZYC3-002 ZYC300 plasmid DNA cyclophosphamide Cytoxan advanced breast cancer advanced ovarian cancer hormone refractory prostate cancer advanced colon cancer |
advanced renal cancer advanced stage malignancies immune therapy gene therapy biologic therapy T-regulatory cells cancer vaccine vaccine Advanced stage malignancies-ovary, breast, colon, prostate |
|
Breast Neoplasms Colonic Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Ovarian Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |