Trial reportBMC cancer2011
Phase II trial of the regulatory T cell-depleting agent, denileukin diftitox, in patients with unresectable stage IV melanoma.
Trial report in BMC cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00299689 (Phase II Trial of ONTAK With Metastatic Melanoma), which is not on this map. Cited by 30 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.
Phase II Trial of ONTAK With Metastatic Melanoma
Who cites it
30 citing papers in PubMed, 76 citations in OpenAlex.
- Mechanisms of Epstein-Barr virus nuclear antigen 1 favor Tregs accumulation in nasopharyngeal carcinoma.Cancer medicine · 2020Trial
- Review
- CAR T cells targeting CCR4 selectively deplete human Tregs ex vivo and in vivo.Blood advances · 2026Article
- Review
- Review
- CCL19/CCR7 drives regulatory T cell migration and indicates poor prognosis in gastric cancer.BMC cancer · 2023Article
- Insights into N6-methyladenosine (m6A) modification of noncoding RNA in tumor microenvironment.Aging · 2023Review
- Crosstalk between N6-methyladenosine (m6A) modification and noncoding RNA in tumor microenvironment.International journal of biological sciences · 2023Review
- Targeting regulatory T cells by E7777 enhances CD8 T-cell-mediated anti-tumor activity and extends survival benefit of anti-PD-1 in solid tumor models.Frontiers in immunology · 2023Article
- The role of macrophages-mediated communications among cell compositions of tumor microenvironment in cancer progression.Frontiers in immunology · 2023Review
- Melanoma therapeutics: a literature review.Journal of biomedical research · 2022Article
- So Pathogenic or So What?-A Brief Overview of SIV Pathogenesis with an Emphasis on Cure Research.Viruses · 2022Review
- Fighting Cancer with Bacteria and Their Toxins.International journal of molecular sciences · 2021Review
- Nonhuman Primate Testing of the Impact of Different Regulatory T Cell Depletion Strategies on Reactivation and Clearance of Latent Simian Immunodeficiency Virus.Journal of virology · 2020Article
- Recent advances with Treg depleting fusion protein toxins for cancer immunotherapy.Immunotherapy · 2019Review
- Review
- Second-generation IL-2 receptor-targeted diphtheria fusion toxin exhibits antitumor activity and synergy with anti-PD-1 in melanoma.Proceedings of the National Academy of Sciences of the United States of America · 2019Article
- Melanoma treatment in review.ImmunoTargets and therapy · 2018Review
- Regulatory T Cells As Potential Targets for HIV Cure Research.Frontiers in immunology · 2018Review
- Suppressor Cell-Depleting Immunotherapy With Denileukin Diftitox is an Effective Host-Directed Therapy for Tuberculosis.The Journal of infectious diseases · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe previously found that administration of an interleukin 2/diphtheria toxin conjugate (DAB/IL2; Denileukin Diftitox; ONTAK) to stage IV melanoma patients depleted CD4(+)CD25(HI)Foxp3(+) regulatory T cells and expanded melanoma-specific CD8(+) T cells. The goal of this study was to assess the clinical efficacy of DAB/IL2 in an expanded cohort of stage IV melanoma patients.
methodsIn a single-center, phase II trial, DAB/IL2 (12 μg/kg; 4 daily doses; 21 day cycles) was administered to 60 unresectable stage IV melanoma patients and response rates were assessed using a combination of 2-[(18)F]-fluoro-2-deoxy-glucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.
resultsAfter DAB/IL2 administration, 16.7% of the 60 patients had partial responses, 5% stable disease and 15% mixed responses. Importantly, 45.5% of the chemo/immuno-naïve sub-population (11/60 patients) experienced partial responses. One year survival was markedly higher in partial responders (80 ± 11.9%) relative to patients with progressive disease (23.7 ± 6.5%; p value < 0.001) and 40 ± 6.2% of the total DAB/IL2-treated population were alive at 1 year.
conclusionsThese data support the development of multi-center, randomized trials of DAB/IL2 as a monotherapy and in combination with other immunotherapeutic agents for the treatment of stage IV melanoma.
trial registrationNCT00299689.
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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.