Trial reportGynecologic oncology2014
A phase II trial of intraperitoneal EGEN-001, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a gynecologic oncology group study.
Trial report in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
36 citing papers in PubMed, 77 citations in OpenAlex.
- Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study.Gynecologic oncology · 2018Trial
- Advances in Polyethyleneimine-Derived Nanoformulations.Small science · 2026Review
- A novel mRNA-based multi-cytokine strategy to reprogram the peritoneal tumor microenvironment in ovarian cancer.Journal of nanobiotechnology · 2026Article
- Rewriting Tumor Entry Rules: Microfluidic Polyplexes and Tumor-Penetrating Strategies-A Literature Review.Pharmaceutics · 2026Review
- Nanotechnology for immuno-oncology.Nature cancer · 2025Review
- Nanomedicine innovations in colon and rectal cancer: advances in targeted drug and gene delivery systems.Medical oncology (Northwood, London, England) · 2025Review
- Uncovering the interleukin-12 pharmacokinetic desensitization mechanism and its consequences with mathematical modeling.CPT: pharmacometrics & systems pharmacology · 2025Article
- Present and future of cancer nano-immunotherapy: opportunities, obstacles and challenges.Molecular cancer · 2025Review
- Intraperitoneal immunotherapy with denileukin diftitox (ONTAK) in recurrent refractory ovarian cancer.Gynecologic oncology · 2024Article
- Lipid-based nanosystems: the next generation of cancer immune therapy.Journal of hematology & oncology · 2024Review
- Tumor Immune Microenvironment in Gynecologic Cancers.Cancers · 2023Review
- Interleukin-12 as an in situ cancer vaccine component: a review.Cancer immunology, immunotherapy : CII · 2022Review
- IL12 immune therapy clinical trial review: Novel strategies for avoiding CRS-associated cytokines.Frontiers in immunology · 2022Review
- Integrating Cancer Vaccines in the Standard-of-Care of Ovarian Cancer: Translating Preclinical Models to Human.Cancers · 2021Review
- Cell-Based Delivery Approaches for DNA-Binding Domains to the Central Nervous System.Current neuropharmacology · 2021Review
- Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.Frontiers in cell and developmental biology · 2020Review
- Localized Interleukin-12 for Cancer Immunotherapy.Frontiers in immunology · 2020Review
- Polymeric vehicles for nucleic acid delivery.Advanced drug delivery reviews · 2020Review
- Overcoming Resistance to Natural Killer Cell Based Immunotherapies for Solid Tumors.Frontiers in oncology · 2019Review
- Clinical Evaluations of Toxicity and Efficacy of Nanoparticle-Mediated Gene Therapy.Human gene therapy · 2018Review
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveThe purpose of this phase II trial was to evaluate the toxicity and antitumor activity of EGEN-001 in platinum resistant recurrent ovarian cancer.
methodsEligible patients had weekly IP infusion of EGEN-001 at a dose of 24mg/m(2). Toxicity and antitumor activity were evaluated using CTCAE and RESIST criteria, respectively. Co-primary endpoints were tumor response and survival without progression (PFS) for at least 6months. Survival without progression before going onto a subsequent therapy (EFS) for at least six months was also considered.
resultsA total of 58 EGEN-001 cycles were administered to 20/22 enrolled patients (median 2cycles, range 1-9). The most frequently associated adverse events related specifically to EGEN-001 treatment were grade 1/2 fatigue, fever, chills, abdominal pain, nausea, vomiting, anemia, thrombocytopenia, and leukopenia. Three of 20 EGEN-001 treated patients evaluable for toxicity elected to withdraw from the study motivated in part by grade 1 treatment related toxicities. There were no patients with partial or complete response (0%; 90% CI 0-10.9%). Seven (35%) of 16 patients evaluable for response had stable disease, and 9 (45%) had progressive disease. Six (30%) patients had a PFS of greater than six months, although three had gone off study and onto other therapies before six months. The estimated six-month EFS was 15%. The median PFS and OS were 2.89 and 9.17months, respectively.
conclusionEGEN-001 at the dose and schedule evaluated was associated with some but limited activity and was seemingly less tolerated in platinum resistant recurrent ovarian cancer patients.
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