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A Phase I/II Study of the Safety and Biological Activity of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients Who Had Previously Received Cytoreductive Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Therapy


Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase I/II Study of the Safety and Biological Activity of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients Who Had Previously Received Cytoreductive Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Therapy


This multi-center, Phase I/II study will be conducted with an open-label, non-randomized
design. The study will enroll up to 30 patients who had gone through cytoreductive surgery
and HIPEC treatment 6-8 weeks prior to enrollment. Patients will be treated with EGEN-001 24
mg/m2 intra-peritoneally (IP) once every week for 12 weeks and then once every two weeks
until disease progression or intolerable toxicity, but for no more than one year. Patients
who develop progressive metastases will receive standard chemotherapy concomitant with
EGEN-001. Hence, the initial EGEN-001 treatment period will be without chemotherapy. The
standard chemotherapy regimen will be FOLFOX or FOLFIRI administered every 2-3 weeks.
Patient with progressive disease a second time will be taken off-study. Those who remain
progression-free will receive EGEN-001 for up to one year.


Inclusion Criteria:



- At least 18 years of age (or minimum legal age and competency to provide voluntary
written informed consent for study participation) and no more than 80 years of age.

- Patients must have colorectal carcinoma (including appendiceal) with metastases
limited to peritoneal cavity. Histological documentation of the original primary
tumor is required via pathology report.

- Patients must have completed surgical debulking + hyperthermic intraperitoneal
chemotherapy (mitomycin) and have had a peritoneal catheter inserted 6-8 weeks before
beginning infusion with IP EGEN-001 and must have post-debulking peritoneal cancer
index (PCI) of <2. Patients do not have to have measurable metastases by RECIST
criteria following surgical debulking.

- Patients may have received previous systemic chemotherapy for colorectal cancer, but
this is not required.

- Patients must have an ECOG Performance Status of 0, 1, or 2.

- Any other prior therapy directed at the malignant tumor, including biological and
immunologic agents, must be discontinued at least three weeks prior to enrollment.

- Patients should be free of active infection requiring antibiotics (with the exception
of uncomplicated UTI.)

- Patients must have adequate:

1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1,500/mcl, equivalent to the Active Version of the NCI Common Terminology
Criteria (CTCAE) grade 1. Platelets greater than or equal to 100,000/mcl.

2. Renal function: creatinine less than or equal to 1.5 x institutional upper limit
normal (ULN), per the Active Version of the NCI CTCAE grade 1.

3. Hepatic function: Bilirubin less than or equal to 1.5 x ULN (per the Active
Version of the NCI CTCAE grade 1). SGOT (AST) less than or equal to 3 x ULN (per
the Active Version of the NCI CTCAE grade 1) and alkaline phosphatase less than
or equal to 2.5 x ULN (per the Active Version of the NCI CTCAE grade 1).

4. Neurologic function: Neuropathy (sensory and motor) less than or equal to the
Active Version of the NCI CTCAE grade 1.

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information.

- Women of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception. Female partners of
childbearing potential of male patients must also use an effective form of
contraception. Contraception must be used for 90 days following the last dose of
EGEN-001.

Exclusion Criteria:

- Patients who have had prior therapy with EGEN-001 or IL-12.

- Prior radiation therapy to the abdomen or pelvis less than 6 months prior to entering
the study.

- Patients with a serious uncontrolled medical illness or disorder or active infection
within four weeks of study entry.

- Patients with any condition/anomaly that would interfere with the appropriate
placement of the IP catheter for study drug administration including: intestinal
dysfunction or suspected extensive adhesions from prior history or finding at
laparoscopy.

- Metastases beyond the peritoneal cavity including liver, lung or retroperitoneal
lymph nodes.

- History of other malignancy other than non-melanoma skin cancer or in situ cervical
carcinoma within the last 5 years.

- The patient is pregnant or lactating.

- The patient has taken an investigational agent in the preceding 4 weeks.

- Patients with a history of HIV, hepatitis B or hepatitis C.

- Patients who require treatment with pharmacologic doses of systemic steroids;
replacement doses, topical, inhalation and ophthalmic steroid use is permitted.

- Patients who are allergic to any of the components of EGEN-001.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

EGEN-001-301

NCT ID:

NCT01300858

Start Date:

June 2011

Completion Date:

March 2017

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Carcinoma

Name

Location

Midwestern Regional Medical CenterZion, Illinois  60099