Ovarian NeoplasmsPhase 1NCT00137865
Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer
A Phase 1 study testing EGEN-001 (phIL-12-005/PPC) in people with Ovarian Neoplasms, run by EGEN, Inc. at 1 site in United States.
Trial summary
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- EGEN-001 (phIL-12-005/PPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2006
- Phase
- Phase 1
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and at least 19 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation)
- Have received previous treatment for ovarian cancer that included a platinum based chemotherapy regimen
- Have recurrent epithelial ovarian cancer
- Have a measurable tumor by computed tomography (CT) scan according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Have an ECOG performance status score of 0, 1, or 2
- If of childbearing potential, agree to follow an acceptable method of birth control (e.g., abstinence, intrauterine device [IUD] or barrier method), as determined by the investigator, for the duration of the study. Hormonal contraceptives should not be used as the sole method of birth control.
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- Have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/µL;
- Absolute neutrophil count ≥ 1,500/µL;
- Platelets ≥ 100,000/µL;
- Total bilirubin within institutional limits;
- SGOT/SGPT ≤ 2.5 X institutional upper limit of normal (ULN);
- Creatinine within institutional normal limits; OR creatinine clearance ≥ 60mL/min/1.73m2 for patients with creatinine levels above institutional normal.
- Have electrocardiogram (ECG) without clinically significant abnormality, as determined by a qualified cardiologist
- Have the capability (caregiver) of performing IP site care while at home
Who cannot join
- A serious uncontrolled intercurrent medical illness or disorder including, but not limited to, ongoing or active infection, abdominal surgery, autoimmune disorders, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which would limit compliance with study requirements
- Intraabdominal disease > 5 (five) centimeters in diameter
- Previous treatment with whole abdominal irradiation
- Intestinal dysfunction or suspected extensive adhesions from prior history or findings at laparoscopy
- Intrahepatic disease
- Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
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- Received investigational agents within three months prior to study drug dosing
- Receipt of any medications (in particular, systemic or topical steroids) or substances known to affect, or with the potential to affect, the activity of EGEN-001
- Life expectancy of less than three months
- Known human immunodeficiency virus (HIV) infection
- Positive HbsAg
- Positive hepatitis C virus (HCV) serology
- Prior IP drug administration
- Prior immunotherapy for ovarian cancer
- Chemotherapy within four weeks prior to placement of IP catheter
- Radiotherapy within eight weeks prior to placement of IP catheter
- Contraindication (either allergy or impaired renal function) to injection with contrast media for adequate evaluation of tumor size by CT scan
- Pregnant or breast feeding an infant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the human gene for interleukin-12 [IL-12] (a cytokine) in a special carrier system designed to enter the cells and help the body produce cytokines.
This study has two purposes; the first is to determine what different strengths of EGEN-001 can be given safely without major side effects, and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer.
Read the detailed description
EGEN-001-101 is a Phase 1, open label, non-randomized, dose escalation study in up to 18 (eighteen) patients (three to six patients in each of the first three cohorts, and up to nine patients in a fourth cohort or MTD). The fourth cohort (or MTD, if earlier) will be expanded in increments of three patients until a total of 18 patients have been enrolled.
Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study. Screening evaluations will be performed within 21 days prior to scheduled study drug administration. If all eligibility criteria are met, the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the catheter insertion site. Baseline evaluations will be performed prior to dosing. At that time the investigator will ensure that the patient remains eligible for participation.
All study drug will be administered on an inpatient basis and the patient will remain confined for 24 hours following study drug administration for evaluation of safety and collection of specified body fluid samples for plasmid IL-12-DNA and cytokine determinations. Each patient will receive the same dose of EGEN-001 once weekly for four weeks (administered on Day 0, Day 7, Day 14, and Day 21). Patients will undergo safety evaluations 1, 4 and 24 hours and 3 days following each dose. Patients will return to the clinic for safety evaluations three days, one week and five weeks (± one week) following the last dose.
- Conditions
- Ovarian Neoplasms
- Being tested
- EGEN-001 (phIL-12-005/PPC)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGEN-001 (phIL-12-005/PPC)Genetic
| Study group | Role | What they receive |
|---|---|---|
| EGEN-001 | Experimental | Not described Receives: Genetic: EGEN-001 (phIL-12-005/PPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer
Secondary outcomes (3)
To assess the preliminary efficacy of EGEN-001 by monitoring detectable tumor burden in patients with recurrent epithelial cancer
To assess EGEN-001 distribution by measuring human interleukin-12 plasmid (phIL-12) DNA copy number in the blood and peritoneal fluid
To assess the biological effects of EGEN-001 on cytokine production by measuring interferon (IFN) gamma and interleukin-12 (IL-12) concentrations in the blood and peritoneal fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- EGEN, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Alvarez, MD, Principal investigator, Divison of Gynecologic Oncology at University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137865
- Sponsor's protocol ID
- EGEN-001-101
- Status last verified
- Feb 2013
- First submitted
- 26 Aug 2005
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00137865
- Acronym / sponsor ID
- EGEN-001-101
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- EGEN, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 30 Aug 2005 (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.
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the human gene for interleukin-12 [IL-12] (a cytokine) in a special carrier system designed to enter the cells and help the body produce cytokines.
This study has two purposes; the first is to determine what different strengths of EGEN-001 can be given safely without major side effects, and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer.
Detailed description
EGEN-001-101 is a Phase 1, open label, non-randomized, dose escalation study in up to 18 (eighteen) patients (three to six patients in each of the first three cohorts, and up to nine patients in a fourth cohort or MTD). The fourth cohort (or MTD, if earlier) will be expanded in increments of three patients until a total of 18 patients have been enrolled.
Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study. Screening evaluations will be performed within 21 days prior to scheduled study drug administration. If all eligibility criteria are met, the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the catheter insertion site. Baseline evaluations will be performed prior to dosing. At that time the investigator will ensure that the patient remains eligible for participation.
All study drug will be administered on an inpatient basis and the patient will remain confined for 24 hours following study drug administration for evaluation of safety and collection of specified body fluid samples for plasmid IL-12-DNA and cytokine determinations. Each patient will receive the same dose of EGEN-001 once weekly for four weeks (administered on Day 0, Day 7, Day 14, and Day 21). Patients will undergo safety evaluations 1, 4 and 24 hours and 3 days following each dose. Patients will return to the clinic for safety evaluations three days, one week and five weeks (± one week) following the last dose.
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 | Genetic: EGEN-001 (phIL-12-005/PPC) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female and at least 19 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation)
- Have received previous treatment for ovarian cancer that included a platinum based chemotherapy regimen
- Have recurrent epithelial ovarian cancer
- Have a measurable tumor by computed tomography (CT) scan according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Have an ECOG performance status score of 0, 1, or 2
Key exclusion criteria (18 listed)
- A serious uncontrolled intercurrent medical illness or disorder including, but not limited to, ongoing or active infection, abdominal surgery, autoimmune disorders, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations which would limit compliance with study requirements
- Intraabdominal disease > 5 (five) centimeters in diameter
- Previous treatment with whole abdominal irradiation
- Intestinal dysfunction or suspected extensive adhesions from prior history or findings at laparoscopy
- Intrahepatic disease
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 (phIL-12-005/PPC) | Genetic | EGEN-001 |
Primary outcome
To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer
3 secondary outcomes
To assess the preliminary efficacy of EGEN-001 by monitoring detectable tumor burden in patients with recurrent epithelial cancer
To assess EGEN-001 distribution by measuring human interleukin-12 plasmid (phIL-12) DNA copy number in the blood and peritoneal fluid
To assess the biological effects of EGEN-001 on cytokine production by measuring interferon (IFN) gamma and interleukin-12 (IL-12) concentrations in the blood and peritoneal fluid
Results and safety
The study was stopped early (reason given: Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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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.
Ronald Alvarez, MD principal investigator
Divison of Gynecologic Oncology at University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EGEN-001 (phIL-12-005/PPC) in people with Ovarian Neoplasms, 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 15 inclusion and 18 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 28 Feb 2013. 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 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.
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: Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.). 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?
To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer. 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 28 Feb 2013.