Colorectal CancerPhase 1/2NCT01300858
A Study of the Safety and Biological Activity of Intraperitoneal (IP) EGEN-001 Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients
A Phase 1/2 study testing EGEN-001-301 in people with Colorectal Cancer, run by EGEN, Inc. at 1 site in United States.
Trial summary
Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- EGEN-001-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI.)
- Patients must have adequate:
- 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.
- 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.
- 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).
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
Official title: 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
Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- EGEN-001-301
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGEN-001-301Drug
Patients will be treated with EGEN-001 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.
| Study group | Role | What they receive |
|---|---|---|
| EGEN-001 | Experimental | Not described Receives: Drug: EGEN-001-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 5 years
Overall survival
Measured: 5 years
Tumor Growth Assessment by X-ray/CT
Measured: 1 year
Secondary outcomes (1)
Number of study subjects with adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Sites could not enroll patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- EGEN, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300858
- Sponsor's protocol ID
- EGEN-001-301
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2011
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01300858
- Acronym / sponsor ID
- EGEN-001-301
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sites could not enroll patients.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EGEN, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGEN-001 | Experimental | Drug: EGEN-001-301 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGEN-001-301Patients will be treated with EGEN-001 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. | Drug | EGEN-001 |
Primary outcome
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Tumor Growth Assessment by X-ray/CT
Time frame: 1 year
1 secondary outcome
Number of study subjects with adverse events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Sites could not enroll patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EGEN-001-301 in people with Colorectal Cancer, run by EGEN, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sites could not enroll patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.