ArticleCancer gene therapy2008
Phase I trial of DNA-hsp65 immunotherapy for advanced squamous cell carcinoma of the head and neck.
Article in Cancer gene therapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Ultrasound-guided intra-tumoral administration of directly-injected therapies: a review of the technical and logistical considerations.Cancer imaging : the official publication of the International Cancer Imaging Society · 2024Review
- Immunotherapeutic Activities of a DNA Plasmid Carrying the Mycobacterial hsp65 Gene (DNAhsp65).Frontiers in medical technology · 2020Review
- Folic acid-decorated polyamidoamine dendrimer exhibits high tumor uptake and sustained highly localized retention in solid tumors: Its utility for local siRNA delivery.Acta biomaterialia · 2017Article
- Mycobacterial Hsp65 antigen upregulates the cellular immune response of healthy individuals compared with tuberculosis patients.Human vaccines & immunotherapeutics · 2017Article
- Review
- New strategy for testing efficacy of immunotherapeutic compounds for diabetes in vitro.BMC biotechnology · 2016Article
- Combined immunization using DNA-Sm14 and DNA-Hsp65 increases CD8+ memory T cells, reduces chronic pathology and decreases egg viability during Schistosoma mansoni infection.BMC infectious diseases · 2014Article
- A snapshot of gene therapy in Latin America.Genetics and molecular biology · 2014Review
- Therapeutic DNA vaccine reduces schistosoma mansoni-induced tissue damage through cytokine balance and decreased migration of myofibroblasts.The American journal of pathology · 2011Article
- Article
- Expression of Mycobacterium leprae HSP65 in tobacco and its effectiveness as an oral treatment in adjuvant-induced arthritis.Transgenic research · 2011Article
- HSP60: issues and insights on its therapeutic use as an immunoregulatory agent.Frontiers in immunology · 2011Article
- The impact of transcriptomics on the fight against tuberculosis: focus on biomarkers, BCG vaccination, and immunotherapy.Clinical & developmental immunology · 2011Review
- Helminth coinfection does not affect therapeutic effect of a DNA vaccine in mice harboring tuberculosis.PLoS neglected tropical diseases · 2010Article
- Tumor immunogenicity and responsiveness to cancer vaccine therapy: the state of the art.Seminars in immunology · 2010Review
- Strategies for cancer vaccine development.Journal of biomedicine & biotechnology · 2010Review
- The current state of head and neck cancer gene therapy.Human gene therapy · 2009Review
- Immune response to vaccination with DNA-Hsp65 in a phase I clinical trial with head and neck cancer patients.Cancer gene 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
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Considering that mycobacterial heat-shock protein 65 (hsp65) gene transfer can elicit a profound antitumoral effect, this study aimed to establish the safety, maximum-tolerated dose (MTD) and preliminary efficacy of DNA-hsp65 immunotherapy in patients with advanced head and neck squamous cell carcinoma (HNSCC). For this purpose, 21 patients with unresectable and recurrent HNSCC were studied. Each patient received three ultrasound-guided injections at 21-day intervals of: 150, 600 or 400 microg of DNA-hsp65. Toxicity was graded according to CTCAE directions. Tumor volume was measured before and after treatment using computed tomography scan. The evaluation included tumor mass variation, delayed-type hypersensitivity response and spontaneous peripheral blood mononuclear cell proliferation before and after treatment. The MTD was 400 microg per dose. DNA-hsp65 immunotherapy was well tolerated with moderate pain, edema and infections as the most frequent adverse effects. None of the patients showed clinical or laboratory alterations compatible with autoimmune reactions. Partial response was observed in 4 out of 14 patients who completed treatment, 2 of which are still alive more than 3 years after the completion of the trial. Therefore, DNA-hsp65 immunotherapy is a feasible and safe approach at the dose of 400 microg per injection in patients with HNSCC refractory to standard treatment. Further studies in a larger number of patients are needed to confirm the efficacy of this novel strategy.
Indexed as
Identifiers
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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.