Trial reportGene therapy2001
Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: safety, feasibility and biological activity.
Trial report in Gene therapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 101 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
101 citing papers in PubMed, 1 synthesis or guideline pooled it, 280 citations in OpenAlex.
- A bibliometric review of oncolytic virus research as a novel approach for cancer therapy.Virology journal · 2021Pooled it
- Phase I-II trial of ONYX-015 in combination with MAP chemotherapy in patients with advanced sarcomas.Gene therapy · 2005Trial
- Pilot trial of intravenous infusion of a replication-selective adenovirus (ONYX-015) in combination with chemotherapy or IL-2 treatment in refractory cancer patients.Cancer gene therapy · 2003Trial
- Intra-arterial administration of a replication-selective adenovirus (dl1520) in patients with colorectal carcinoma metastatic to the liver: a phase I trial.Gene therapy · 2001Trial
- Leveraging the bacteria for enhanced cancer immunotherapy: from a perspective of synthetic biology.Cancer biology & therapy · 2026Review
- Advances in oncolytic virus delivery strategies and challenges in clinical translation.Materials today. Bio · 2026Review
- Recombinant adenoviruses application for cancer vaccines: from genetic design to clinical translation.Frontiers in oncology · 2026Review
- Advances in interleukin-10-based therapies for pulmonary diseases: focus on targeted lung delivery systems.Frontiers in immunology · 2025Review
- An oncolytic virus-T cell chimera for cancer immunotherapy.Nature biotechnology · 2024Article
- Systemic delivery of tannic acid-ferric-masked oncolytic adenovirus reprograms tumor microenvironment for improved therapeutic efficacy in glioblastoma.Cancer gene therapy · 2024Article
- Challenges and strategies toward oncolytic virotherapy for leptomeningeal metastasis.Journal of translational medicine · 2024Review
- Harnessing adenovirus in cancer immunotherapy: evoking cellular immunity and targeting delivery in cell-specific manner.Biomarker research · 2024Review
- Head and Neck Squamous Cell Carcinoma Vaccine: Current Landscape and Perspectives.Current issues in molecular biology · 2023Review
- AAV6 as an effective gene delivery vector for prolonged transgene expression in intervertebral disc cellsGenes & diseases · 2022Article
- Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors.Journal for immunotherapy of cancer · 2022Article
- A Simplified SARS-CoV-2 Mouse Model Demonstrates Protection by an Oral Replicon-Based mRNA Vaccine.Frontiers in immunology · 2022Article
- Pouring petrol on the flames: Using oncolytic virotherapies to enhance tumour immunogenicity.Immunology · 2021Review
- Ad5/3 is able to avoid neutralization by binding to erythrocytes and lymphocytes.Cancer gene therapy · 2021Article
- Delivery and Biosafety of Oncolytic Virotherapy.Frontiers in oncology · 2020Review
- Phase I trial of intravenous Ad5CRT in patients with liver metastasis of gastrointestinal cancers.Cancer gene therapy · 2019Article
41 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although genetically engineered adenoviruses hold promise for the treatment of cancer, clinical trial reports have utilized intratumoral injection to date. To determine the feasibility of intravenous delivery of ONYX-015, an E1B-55kD gene-deleted replication selective adenovirus with demonstrated clinical safety and antitumoral activity following intratumoral injection, we performed a clinical trial in patients with metastatic solid tumors. ONYX-015 was infused intravenously at escalating doses of 2 x 10(10) to 2 x 10(13) particles via weekly infusion within 21-day cycles in 10 patients with advanced carcinoma metastatic to the lung. No dose-limiting toxicity was identified. Mild to moderate fever, rigors and a dose-dependent transient transaminitis were the most common adverse events. Neutralizing antibody titers significantly increased within 3 weeks in all patients. IL-6, gamma-IFN, TNF-alpha and IL-10 increased within 24 h following treatment. Evidence of viral replication was detectable in three of four patients receiving ONYX-015 at doses > or = 2 x 10(12) particles and intratumoral replication was confirmed in one patient. In conclusion, intravenous infusion of ONYX-015 was well tolerated at doses up to 2 x 10(13) particles and infection of metastatic pulmonary sites with subsequent intratumoral viral replication was seen. The intravenous administration of genetically altered adenovirus is a feasible approach.
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.