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Fallopian Tube CarcinomaPhase 2NCT01118052

EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 2 study testing Laboratory Biomarker Analysis and PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 in people with Fallopian Tube Carcinoma and Primary Peritoneal Carcinoma, run by Gynecologic Oncology Group at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies the side effects and how well EGEN-001 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Laboratory Biomarker Analysis and PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
11 sitesUnited States
Study dates
1 Nov 2010to 16 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI; patients must have evidence of intra-abdominal/pelvic disease; patients with disease exclusively located outside of the abdominal/pelvic cavity are not eligible
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
  • Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
  • Patients who have received two prior regimens must have a GOG performance status of 0 or 1
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  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted therapy and immunologic agents, must be discontinued at least three weeks prior to registration
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
  • Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
  • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
  • Note: patients on this non-cytotoxic study are allowed to receive additional cytotoxic chemotherapy for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
  • Absolute neutrophil count (ANC) greater or equal to 1,500/mcl
  • Platelet count greater or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance greater than or equal to 50 mL/min; any evidence of renal obstruction must be corrected prior to treatment
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception

Who cannot join

  • Patients who have had previous treatment with EGEN-001
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted above are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients with a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
  • Patients with a serious uncontrolled medical illness or disorder, abdominal surgery (for reasons other than IP port placement) or active infection within four weeks of study entry; patients may have surgery for the purpose of IP port placement greater than or equal to one week(s) before study entry and treatment
  • Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction or suspected extensive adhesions from prior history or finding at laparoscopy
  • Patients who are pregnant or breastfeeding

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Gynecologic Oncology Group of Arizona

    Phoenix, Arizona, 85012

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This phase II trial studies the side effects and how well EGEN-001 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Biological therapies, such as EGEN-001, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.

II. To determine the frequency and severity of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

SECONDARY OBJECTIVES:

  1. To determine the duration of progression-free survival and overall survival.

TERTIARY OBJECTIVES:

  1. To collect blood and peritoneal lavage fluid from patients that will be stored for future research.

OUTLINE:

Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Laboratory Biomarker Analysis, PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1Biological

    Given intraperitoneally

Study groups in NCT01118052
Study groupRoleWhat they receive
Treatment (EGEN-001)ExperimentalPatients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Biological: PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients Who Survive Progression-free for at Least 6 Months

    Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression

    Measured: Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years

  2. Patients Who Have Objective Tumor Response (Complete or Partial Response)

    Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 years

  3. Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0

    Adverse events are listed by adverse event and grade. The number of participants affected is listed.

    Measured: All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatment

Secondary outcomes (2)

  1. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact.

    Measured: The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years

  2. Progression-free Survival

    The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.

    Measured: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2010 (estimated)
  2. Study start1 Nov 2010
  3. Primary completion16 Jul 2016
  4. Study completion16 Jul 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01118052
Sponsor's protocol ID
GOG-0170Q
Other IDs
NCI-2011-02041, FD-R-003942, CDR0000672159, GOG-0170Q, GOG-0170Q, U10CA180868, U10CA027469
Status last verified
Aug 2017
First submitted
5 May 2010
Last updated
11 Jan 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 in people with Fallopian Tube Carcinoma and Primary Peritoneal Carcinoma, run by Gynecologic Oncology Group at 11 sites 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 25 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 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?

Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patients Who Survive Progression-free for at Least 6 Months (time frame: Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 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?

On the ClinicalTrials.gov record for NCT01118052.

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 11 Jan 2018.

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