Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2010
Advanced phase I/II studies of targeted gene delivery in vivo: intravenous Rexin-G for gemcitabine-resistant metastatic pancreatic cancer.
Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.
- Clinical Outcomes of Specific Immunotherapy in Advanced Pancreatic Cancer: A Systematic Review and Meta-Analysis.Journal of immunology research · 2017Pooled it
- Targeted drug delivery systems for pancreatic cancer therapy: advances, challenges, and future perspectives.Frontiers in immunology · 2026Review
- Advances in HIV Gene Therapy.International journal of molecular sciences · 2024Review
- Phase I-II study using DeltaRex-G, a tumor-targeted retrovector encoding a cyclin G1 inhibitor for metastatic carcinoma of breast.Frontiers in molecular medicine · 2023Article
- Three year results of Blessed: Expanded access for DeltaRex-G for an intermediate size population with advanced pancreatic cancer and sarcoma (NCT04091295) and individual patient use of DeltaRex-G for solid malignancies (IND# 19130).Frontiers in molecular medicine · 2022Article
- Protection is not always a good thing: The immune system's impact on gene therapy.Genetics and molecular biology · 2022Article
- Targeting Engineered Nanoparticles for Breast Cancer Therapy.Pharmaceutics · 2021Review
- Biomarkers in Pancreatic Cancer as Analytic Targets for Nanomediated Imaging and Therapy.Materials (Basel, Switzerland) · 2021Review
- A Phase I-II Study Using Rexin-G Tumor-Targeted Retrovector Encoding a Dominant-Negative Cyclin G1 Inhibitor for Advanced Pancreatic Cancer.Molecular therapy oncolytics · 2019Article
- Development and Clinical Translation of Approved Gene Therapy Products for Genetic Disorders.Frontiers in genetics · 2019Review
- Exploiting Oncogenic Drivers along theMolecular therapy oncolytics · 2018Review
- Gene Therapy for Pancreatic Diseases: Current Status.International journal of molecular sciences · 2018Review
- Cell cycle checkpoint control: The cyclin G1/Mdm2/p53 axis emerges as a strategic target for broad-spectrum cancer gene therapy - A review of molecular mechanisms for oncologists.Molecular and clinical oncology · 2018Article
- Current status and dilemma of second-line treatment in advanced pancreatic cancer: is there a silver lining?OncoTargets and therapy · 2018Review
- Efficacy and Safety of Pancreas-Targeted Hydrodynamic Gene Delivery in Rats.Molecular therapy. Nucleic acids · 2017Article
- Gene Therapy for Pancreatic Cancer: Specificity, Issues and Hopes.International journal of molecular sciences · 2017Review
- Rexin-GMolecular and clinical oncology · 2017Article
- Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.Pharmaceutical research · 2016Review
- Nanovectors for anti-cancer drug delivery in the treatment of advanced pancreatic adenocarcinoma.World journal of gastroenterology · 2016Review
- Emerging Therapeutic Potential of Nanoparticles in Pancreatic Cancer: A Systematic Review of Clinical Trials.Biomedicines · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
Rexin-G, a nonreplicative pathology-targeted retroviral vector bearing a cytocidal cyclin G1 construct, was tested in a phase I/II study for gemcitabine-resistant pancreatic cancer. The patients received escalating doses of Rexin-G intravenously from 1 x 10(11) colony-forming units (cfu) 2-3x a week (dose 0-1) to 2 x 10(11) cfu 3x a week (dose 2) for 4 weeks. Treatment was continued if there was less than or equal to grade 1 toxicity. No dose-limiting toxicity (DLT) was observed, and no vector DNA integration, replication-competent retrovirus (RCR), or vector-neutralizing antibodies were noted. In nine evaluable patients, 3/3 patients had stable disease (SD) at dose 0-1. At dose 2, 1/6 patients had a partial response (PR) and 5/6 patients had SD. Median progression-free survival (PFS) was 3 months at dose 0-1, and >7.65 months at dose 2. Median overall survival (OS) was 4.3 months at dose 0-1, and 9.2 months at dose 2. One-year survival was 0% at dose 0-1 compared to 28.6% at dose 2, suggesting a dose-response relationship between OS and Rexin-G dosage. Taken together, these data indicate that (i) Rexin-G is safe and well tolerated, and (ii) Rexin-G may help control tumor growth, and may possibly prolong survival in gemcitabine-resistant pancreatic cancer, thus, earning US Food and Drug Administration's (FDA) fast-track designation as second-line treatment for pancreatic cancer.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.