ArticleBritish journal of cancer2006
A phase I study of intravenous liposomal daunorubicin (DaunoXome) in paediatric patients with relapsed or resistant solid tumours.
Article in British journal of cancer, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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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.
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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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.
- Medulloblastoma in children and adolescents: a systematic review of contemporary phase I and II clinical trials and biology update.Cancer medicine · 2017Pooled it
- Phase I/II Study of CPX-351 Followed by Fludarabine, Cytarabine, and Granulocyte-Colony Stimulating Factor for Children With Relapsed Acute Myeloid Leukemia: A Report From the Children's Oncology Group.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Cardio-oncology for Pediatric and Adolescent/Young Adult Patients.Current treatment options in oncology · 2023Review
- Rationale and design of the Children's Oncology Group study AAML1831 integrated cardiac substudies in pediatric acute myeloid leukemia therapy.Frontiers in cardiovascular medicine · 2023Article
- A Review of Nanotechnology for Treating Dysfunctional Placenta.Frontiers in bioengineering and biotechnology · 2022Review
- Minimizing cardiac toxicity in children with acute myeloid leukemia.Hematology. American Society of Hematology. Education Program · 2021Article
- Effects of Co-Solvent Nature and Acid Concentration in the Size and Morphology of Wrinkled Mesoporous Silica Nanoparticles for Drug Delivery Applications.Molecules (Basel, Switzerland) · 2021Article
- Nanoparticles in pregnancy: the next frontier in reproductive therapeutics.Human reproduction update · 2021Review
- Liposomes: Structure, Biomedical Applications, and Stability Parameters With Emphasis on Cholesterol.Frontiers in bioengineering and biotechnology · 2021Review
- Nanotherapeutics in Neuropathologies: Obstacles, Challenges and Recent Advancements in CNS Targeted Drug Delivery Systems.Current neuropharmacology · 2021Article
- Cardiovascular diseases in survivors of childhood cancer.Cancer metastasis reviews · 2020Review
- The era of bioengineering: how will this affect the next generation of cancer immunotherapy?Journal of translational medicine · 2017Review
- Managing chemotherapy-related cardiotoxicity in survivors of childhood cancers.Paediatric drugs · 2014Review
- Anthracycline-induced cardiotoxicity: a review of pathophysiology, diagnosis, and treatment.Current treatment options in cardiovascular medicine · 2014Article
- Nanomedicines for cancer therapy: state-of-the-art and limitations to pre-clinical studies that hinder future developments.Frontiers in chemistry · 2014Review
- Milatuzumab-conjugated liposomes as targeted dexamethasone carriers for therapeutic delivery in CD74+ B-cell malignancies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Article
- Science and technology of the emerging nanomedicines in cancer therapy: A primer for physicians and pharmacists.SAGE open medicine · 2013Article
- Anthracycline-associated cardiotoxicity in survivors of childhood cancer.Pediatric cardiology · 2011Article
- Cardiovascular effects in childhood cancer survivors treated with anthracyclines.Cardiology research and practice · 2011Article
- Clinical developments in nanotechnology for cancer therapy.Pharmaceutical research · 2011Review
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 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Anthracyclines are widely used in paediatric oncology, but their use is limited by the risk of cumulative cardiac toxicity. Encapsulating anthracyclines in liposomes may reduce cardiac toxicity and possibly increase drug availability to tumours. A phase I study in paediatric patients was designed to establish the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) after a single course of liposomal daunorubicin, 'DaunoXome', as a 1 h infusion on day 1 of a 21 day cycle. Patients were stratified into two groups according to prior treatment: Group A (conventional) and group B (heavily pretreated patients). Dose limiting toxicity was expected to be haematological, and a two-step escalation was planned, with and without G-CSF support. Pharmacokinetic studies were carried out in parallel. In all, 48 patients aged from 1 to 18 years were treated. Dose limiting toxicity was neutropenia for both groups. Maximum tolerated dose was defined as 155 mg m(-2) for Group A and 100 mg m(-2) for Group B. The second phase with G-CSF was interrupted because of evidence of cumulative cardiac toxicity. Cardiac toxicity was reported in a total of 15 patients in this study. DaunoXome shares the early cardiotoxicity of conventional anthracyclines in paediatric oncology. This study has successfully defined a haematological MTD for DaunoXome, but the significance of this is limited given the concerns of delayed cardiac toxicity. The importance of longer-term follow-up in patients enrolled into phase I studies has been underestimated previously, and may lead to an under-recognition of important adverse events.
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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.