GOG-9928

Terminated

Return to Protocol Table

A Phase I Study of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) (IND #12,484) 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

Principal Investigator

Ronald Alvarez, MD

Status

Terminated

Open to Accrual

July 9, 2012

Closed to Accrual

April 27, 2015

Closed to Accrual & Treatment

July 27, 2015

Terminated

January 27, 2018


Disease Site

Gynecologic [GY] Ovarian

Phase

I

Developmental Therapeutics

No

Primary Objective

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of EGEN-001 when administered in combination with pegylated liposomal doxorubicin (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.

To examine the tolerability of the combination at the MTD of EGEN-001 assessed in combination with PLD.

To determine recommended phase II dose (RP2D) of EGEN-001 in combination with PLD.

Patient Population

Women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

Target Accrual

18

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.