ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2013
A phase I dose escalation study of Ad GV.EGR.TNF.11D (TNFerade™ Biologic) with concurrent chemoradiotherapy in patients with recurrent head and neck cancer undergoing reirradiation.
Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 28 citations in OpenAlex.
- Clinical Progress in Virotherapy: Application and Future Prospects in Head and Neck Cancer.International journal of molecular sciences · 2026Review
- Radiation dose, schedule, and novel systemic targets for radio-immunotherapy combinations.Journal of the National Cancer Institute · 2023Article
- Clinical Advances and Future Directions of Oncolytic Virotherapy for Head and Neck Cancer.Cancers · 2023Review
- Enhanced tumor inhibiting effect of 131I-BDI-1-based radioimmunotherapy and cytosine deaminase gene therapy modulated by a radio-sensitive promoter in nude mice bearing bladder cancer.Journal of radiation research · 2023Article
- Immunotherapy in head and neck squamous cell carcinoma: a narrative review.Frontiers of oral and maxillofacial medicine · 2022Article
- Review
- Efficient Delivery and Replication of Oncolytic Virus for Successful Treatment of Head and Neck Cancer.International journal of molecular sciences · 2020Review
- Emerging Concepts and Novel Strategies in Radiation Therapy for Laryngeal Cancer Management.Cancers · 2020Review
- A phase 1 trial of the safety, tolerability and biological effects of intravenous Enadenotucirev, a novel oncolytic virus, in combination with chemoradiotherapy in locally advanced rectal cancer (CEDAR).Radiation oncology (London, England) · 2020Article
- Radiotherapy in Combination With Cytokine Treatment.Frontiers in oncology · 2019Review
- Bone Marrow-Derived Mesenchymal Stem Cell-Mediated Dual-Gene Therapy for Glioblastoma.Human gene therapy · 2019Article
- Radiotherapy as a New Player in Immuno-Oncology.Cancers · 2018Review
- Conditional Regulation of Gene Expression by Ligand-Induced Occlusion of a MicroRNA Target Sequence.Molecular therapy : the journal of the American Society of Gene Therapy · 2018Article
- Combining Oncolytic Adenovirus with Radiation-A Paradigm for the Future of Radiosensitization.Frontiers in oncology · 2017Review
- Review
- Current clinical trials testing the combination of immunotherapy with radiotherapy.Journal for immunotherapy of cancer · 2016Article
- Combinations of immunotherapy and radiation in cancer therapy.Frontiers in oncology · 2014Review
- Molecular therapy in head and neck oncology.Nature reviews. Clinical oncology · 2009Review
- TNFerade, an innovative cancer immunotherapeutic.Indian journal of pharmacologyReview
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundAdGV.EGR.TNF.11D (TNFerade™ Biologic) is a replication-deficient adenoviral vector expressing human tumor necrosis factor alpha (TNF-α) under the control of the chemoradiation-inducible EGR-1 promoter. TNF-α has been shown to function as a radiation sensitizer. We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of TNFerade™ Biologic, when added to chemoradiotherapy in poor prognosis patients with recurrent, previously irradiated head and neck cancer (HNC).
methodsTNFerade™ Biologic was injected intratumorally on day 1 of each 14-day cycle and dose-escalated in log increments from 4 × 10(9) to 4 × 10(11) PU. Daily radiation, infusional 5-fluorouracil (5-FU), and hydroxyurea were given on days 1-5 for seven cycles (FHX). Tumor biopsies were obtained before, during, and after treatment.
resultsFourteen patients were treated. DLT was reached at a dose level of 3 (4 × 10(11) PU) with three thrombotic events. The response rate was 83.3%. The median survival was 9.6 months. One patient (7.1%) remained alive 3 years after treatment. Biopsies were obtained in 90% of patients. Nearly all tumors expressed adenovirus receptors, TNF-α, and TNF-α receptors. Adenoviral DNA was detected in three biopsies from one patient.
conclusionsTNFerade™ Biologic can be safely integrated with FHX chemoradiotherapy at an MTD of 4 × 10(10) PU. Monitoring for thrombotic events is indicated.
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Registered trials
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