A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing
A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing
1 other identifier
interventional
22
1 country
2
Brief Summary
The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Nov 2006
Shorter than P25 for phase_1 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 14, 2013
July 1, 2011
1.9 years
September 26, 2006
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (1)
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.
Within the first 14 days and at each subsequent visit.
Study Arms (1)
1
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- Evidence of measurable disease by clinical or radiographic assessment or by tumor biomarker (ovarian and prostate cancer).
- Age ≥ 18 years old.
- A baseline Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- A life expectancy \> 6 months.
- Adequate hematological function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
- Absolute lymphocyte count ≥ 1,000/mm\^2
- WBC ≥ 3,000/mm\^2
- Platelet count ≥ 75,000/mm\^2
- Hemoglobin ≥ 9 g/dL
- Adequate renal function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as serum creatinine ≤ 1.5 X upper limit of normal.
- Adequate hepatic function established within 14 days prior to receipt of the first dose of cyclophosphamide, defined as:
- Total bilirubin ≤ 1.5 X upper limit of normal, and
- +5 more criteria
You may not qualify if:
- Patients cannot participate in the study if any of the following apply:
- Have a history of parenchymal brain metastases.
- Have received any of the following within 28 days prior to receiving the first dose of cyclophosphamide:
- Chemotherapy
- Radiation therapy
- Immunotherapy
- Systemic immunosuppressive drugs
- Glucocorticoids (inhalers for asthma are permitted)
- Investigational agent or experimental therapy
- Have received three or more biologic/targeted therapies, such as monoclonal antibodies and tyrosine kinase inhibitors.
- Have initiated or reinitiated the use of hormonal agents within 28 days prior to receiving the first dose of cyclophosphamide. These drugs are allowed if treatment was initiated greater than 28 days prior to receipt of the first dose of cyclophosphamide.
- Have a history of bone marrow or stem cell transplantation.
- Have a history of treatment with fludarabine, 2-chlorodeoxyadenosine, 2-deoxycoformycin or similar compounds.
- Have a history of treatment with chronic systemic immunosuppressive drugs.
- Have an immunologic disorder such as immunodeficiency or other chronic auto-immune disease if deemed to be clinically significant.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Gribben JG, Ryan DP, Boyajian R, Urban RG, Hedley ML, Beach K, Nealon P, Matulonis U, Campos S, Gilligan TD, Richardson PG, Marshall B, Neuberg D, Nadler LM. Unexpected association between induction of immunity to the universal tumor antigen CYP1B1 and response to next therapy. Clin Cancer Res. 2005 Jun 15;11(12):4430-6. doi: 10.1158/1078-0432.CCR-04-2111.
PMID: 15958627BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Silverman, MD
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 27, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 14, 2013
Record last verified: 2011-07