Trial reportArchives of gynecology and obstetrics2017
A phase 1/2a, dose-escalation, safety, pharmacokinetic, and preliminary efficacy study of intraperitoneal administration of BC-819 (H19-DTA) in subjects with recurrent ovarian/peritoneal cancer.
Trial report in Archives of gynecology and obstetrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.
- A systematic review of non-coding RNA therapeutics in early clinical trials: a new perspective against cancer.Journal of translational medicine · 2024Pooled it
- RNA therapeutics: current status and future directions.Signal transduction and targeted therapy · 2026Review
- Review
- Review
- Mechanistic roles of long non-coding RNAs in gastric cancer therapy resistance.Non-coding RNA research · 2026Review
- LncRNA-protein interactions: molecular switches for the precise regulation of innate immunity.Frontiers in immunology · 2026Review
- lncRNA H19 as a molecular rheostat in autoimmunity: orchestrating miRNA-mediated gene regulation and immune cell reprogramming.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Exosomal long non-coding RNAs in gastrointestinal cancer: chemoresistance mediators and therapeutic targets.Journal of translational medicine · 2025Review
- Exploring the clinical potential of circulating LncRNAs in breast cancer: insights into primary signaling pathways and therapeutic interventions.Functional & integrative genomics · 2024Review
- Non-coding RNA transcripts, incredible modulators of cisplatin chemo-resistance in bladder cancer through operating a broad spectrum of cellular processes and signaling mechanism.Non-coding RNA research · 2024Review
- Long noncoding RNA H19: functions and mechanisms in regulating programmed cell death in cancer.Cell death discovery · 2024Review
- Innovative therapeutic strategies to overcome radioresistance in breast cancer.Frontiers in oncology · 2024Review
- Long non-coding RNA H19: a potential biomarker and therapeutic target in human malignant tumors.Clinical and experimental medicine · 2023Review
- Long noncoding RNA (lncRNA)Genes & diseases · 2023Review
- The Role of EMT-Related lncRNAs in Ovarian Cancer.International journal of molecular sciences · 2023Review
- Suicide gene strategies applied in ovarian cancer studies.Cancer gene therapy · 2023Review
- HOXA‑AS3 induces tumor progression through the epithelial‑mesenchymal transition pathway in epithelial ovarian cancer.Oncology reports · 2023Article
- Long noncoding RNAs: glycolysis regulators in gynaecologic cancers.Cancer cell international · 2023Review
- From Immunotoxins to Suicide Toxin Delivery Approaches: Is There a Clinical Opportunity?Toxins · 2022Review
- Biological functions, mechanisms, and clinical significance of circular RNA in pancreatic cancer: a promising rising star.Cell & bioscience · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundH19 is a paternally imprinted, oncofetal gene expressed in various embryonic tissues and in 85% of the ovarian tumors. H19-DTA (BC-819) is a DNA plasmid that drives the expression of the diphtheria toxin gene under the regulation of the H19 promoter sequence and therefore is a potential treatment for various tumors that overexpress the H19 gene, among them-ovarian cancer.
objectiveTo assess the safety and efficacy of intra-peritoneal (IP) instillations of H19-DTA (BC-819) plasmid in treating ovarian/peritoneal cancer patients with advanced recurrent disease.
methodsA phase 1-2A multi-centric trial included 14 eligible patients who were either platinum-refractory or platinum-resistant with positive H19 expression. Patients were treated IP with escalating weekly doses of BC-819 for a maximum of 6-9 weeks. Dose-limiting toxicities (DLT) were assessed after the first course of treatment for each patient and each subsequent cohort was enrolled once each subject had completed the first course of treatment and its 4-week follow-up period. The occurrence of adverse events (AEs) and response to treatment were assessed after the induction course and then periodically.
resultsDuring the study, no DLTs were observed. Only 5 grade 1 and 2 AEs, which occurred in 4 patients were considered as possibly related to BC-819. The best tumor response seen was stable disease. Median survivals of 3.2, 5.3 and 6.5 months were observed for the 60, 120 and 240 mg cohorts, respectively.
conclusionsBC-819 can be considered safe and well tolerated in intraperitoneal doses up to 240 mg. Hybridization of intraperitoneal chemotherapy with the biological treatment of BC-819 should be further evaluated in phase 2 and 3 studies.
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