Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Study of Intraperitoneal Egen-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Pegylated Liposomal-Doxorubicin (PLD, Doxil (NSC# 712227 or Lipodox (NSC#673089) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This phase I trial studies the side effects and the best dose of giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has returned after a period of improvement or has not responded to treatment. Biological therapies, such as EGEN-001, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of
EGEN-001 when administered in combination with pegylated liposomal doxorubicin hydrochloride
(PLD; Doxil; Lipodox) every 28 days and the associated DLTs based on adverse events that
occur in cycle 1 for this combination in women with recurrent or persistent epithelial
ovarian, fallopian tube, or primary peritoneal cancer.
II. To examine the tolerability of the combination at the MTD of EGEN-001 assessed in
combination with PLD.
III. To determine recommended phase II dose (RP2D) of EGEN-001 in combination with PLD.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate (complete and partial) in patients with measurable
disease.
TERTIARY OBJECTIVES:
I. Determine the levels and time course of interleukin-12 (IL-12), interferon-gamma
(IFN-gamma), tumor necrosis factor-alpha (TNF-alpha) and vascular endothelial growth factor
(VEGF) following EGEN-001 treatment.
II. Assess the effect of EGEN-001 treatment on the nature of the cellular immune responses by
measuring cell-specific ribonucleic acid (RNA) transcripts.
OUTLINE: This is a dose-escalation study of EGEN-001.
Patients receive pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 60
minutes on day 1 and EGEN-001 intraperitoneally (IP) over 30-60 minutes on days 1, 8, 15, and
22. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up quarterly for up to 1 year.
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