Trial reportCancer gene therapy2003
Pilot trial of intravenous infusion of a replication-selective adenovirus (ONYX-015) in combination with chemotherapy or IL-2 treatment in refractory cancer patients.
Trial report in Cancer gene therapy, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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
32 citing papers in PubMed, 89 citations in OpenAlex.
- Advances in oncolytic virus delivery strategies and challenges in clinical translation.Materials today. Bio · 2026Review
- Harnessing State-of-the-Art Gene Therapy to Transform Oral Cancer Treatment.Biochemical genetics · 2026Review
- Advances in Gene Therapy with Oncolytic Viruses and CAR-T Cells and Therapy-Related Groups.Current issues in molecular biology · 2025Review
- The Evolution and Future of Targeted Cancer Therapy: From Nanoparticles, Oncolytic Viruses, and Oncolytic Bacteria to the Treatment of Solid Tumors.Nanomaterials (Basel, Switzerland) · 2021Review
- Virus-Receptor Interactions and Virus Neutralization: Insights for Oncolytic Virus Development.Oncolytic virotherapy · 2020Review
- Ki67 targeted strategies for cancer therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018Review
- Oncolytic immunotherapy: unlocking the potential of viruses to help target cancer.Cancer immunology, immunotherapy : CII · 2017Review
- Immune System, Friend or Foe of Oncolytic Virotherapy?Frontiers in oncology · 2017Review
- Encapsulation of adenovirus serotype 5 in anionic lecithin liposomes using a bead-based immunoprecipitation technique enhances transfection efficiency.Biomaterials · 2014Article
- Oncoapoptotic markers in oral cancer: prognostics and therapeutic perspective.Molecular diagnosis & therapy · 2014Review
- Oncolytic viruses in head and neck cancer: a new ray of hope in the management protocol.Annals of medical and health sciences research · 2014Review
- Adenovirus vectors for gene therapy, vaccination and cancer gene therapy.Current gene therapy · 2013Review
- An overview of gene therapy in head and neck cancer.Indian journal of human genetics · 2013Review
- Systemic therapy strategies for head-neck carcinomas: Current status.GMS current topics in otorhinolaryngology, head and neck surgery · 2012Article
- Deletion analysis of Ad5 E1a transcriptional control region: impact on tumor-selective expression of E1a and E1b.Cancer gene therapy · 2011Article
- Clinical development directions in oncolytic viral therapy.Cancer gene therapy · 2011Review
- Oncolytic herpes simplex virus vectors and chemotherapy: are combinatorial strategies more effective for cancer?Future oncology (London, England) · 2010Review
- A phase I study of telomerase-specific replication competent oncolytic adenovirus (telomelysin) for various solid tumors.Molecular therapy : the journal of the American Society of Gene Therapy · 2010Article
- Bystander or no bystander for gene directed enzyme prodrug therapy.Molecules (Basel, Switzerland) · 2009Review
- Gene medicine for cancer treatment: commercially available medicine and accumulated clinical data in China.Drug design, development and therapy · 2009Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
ONYX-015 is an adenovirus that selectively replicates in p53 dysfunctional or mutated malignant cells. We performed a pilot trial to determine the safety and feasibility of treatment with ONYX-015 delivered intravenously in patients with advanced malignancy. One cohort of five patients received ONYX-015 once a week for 6 weeks at a dose of 2 x 10(12) particles per infusion in combination with weekly infusions of irinotecan (CPT11, 125 mg per week) and 5-fluorouracil (5FU, 500 mg per week). A second cohort of five patients received the combination of ONYX-015 at a dose of 2 x 10(11) particles per week for 6 weeks in combination with interleukin 2 (IL 2, 1.1 x 10(6) units daily via subcutaneous injection for 5 days each week for 4 weeks). Toxicity attributable to ONYX-015 was limited to transient fever. All patients demonstrated elevations in neutralizing antibody titers within 4 weeks of the infusion of ONYX-015. Serum levels of IL-6, IL-10, tumor necrosis factor-alpha, and interferon-gamma increased within 6 hours of viral infusion, suggesting immune activation. This response was more pronounced in the cohort of patients who received 2 x 10(12) particles per infusion. Two patients demonstrated uptake of viral particles in malignant tissue by quantitative PCR. Electron microscopy confirmed selective cytoplasmic viral particles within malignant cells but not within adjacent normal tissue in a third patient. In conclusion ONYX-015 can be administered safely in combination with CPT11, 5FU or low-dose IL 2 and is able to access malignant tissue following intravenous infusion. Further investigation of ONYX-015, possibly with agents that may modulate replication activity, or duration of virus survival, is indicated.
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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.