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  • Protocol for the TIDAL Melanoma Study: topical imiquimod or diphenylcyclopropenone for the management of cutaneous in-transit melanoma metastases—a phase II, single centre, randomised, pilot study

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Oncology
Protocol
Protocol for the TIDAL Melanoma Study: topical imiquimod or diphenylcyclopropenone for the management of cutaneous in-transit melanoma metastases—a phase II, single centre, randomised, pilot study
  1. Tavis Read1,2,3,
  2. Scott Webber4,5,
  3. Janine Thomas1,
  4. Michael Wagels1,2,
  5. Helmut Schaider4,5,
  6. H Peter Soyer4,5,
  7. B Mark Smithers1,2
  1. 1 Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia
  2. 2 Department of Surgery, The University of Queensland, School of Medicine, Princess Alexandra Hospital, Brisbane, Australia
  3. 3 Griffith University, School of Medicine, Gold Coast, Australia
  4. 4 Dermatology Research Centre, The University of Queensland Diamantina Institute, Brisbane, Australia
  5. 5 Department of Dermatology, The University of Queensland, School of Medicine, Princess Alexandra Hospital, Brisbane, Australia
  1. Correspondence to Dr Tavis Read; tavis.read{at}gmail.com

Abstract

Introduction Patients with in-transit melanoma metastases present a therapeutic challenge. Complete surgical excision of localised disease is considered as the gold standard; however, surgery is not always acceptable and alternatives are required. Treatment results reported using imiquimod and diphenylcyclopropenone (DPCP) suggest that topical immunotherapies can be used to successfully treat select patients with melanoma metastases. A phase II, randomised, single centre, pilot study was designed to assess the clinical efficacy and safety of DPCP and imiquimod for the treatment of superficial, cutaneous in-transit melanoma metastases.

Methods and analysis This is an open-label, non-superiority, pilot study with no treatment cross-over. Eligible patients are randomised in a 1:1 ratio to receive topical therapy for up to 12 months with a minimum follow-up period of 12 months. The target sample size is 30 patients, with 15 allocated to each treatment arm. The primary endpoint is the number of patients experiencing a complete response of treated lesions as determined clinically using Response Evaluation Criteria in Solid Tumours. This trial incorporates health-related quality of life measures and biological tissue collection for further experimental substudies. The study will also facilitate a health economic analysis.

Ethics and dissemination Approval was obtained from the Human Research Ethics Committee at the participating centre, and recruitment has commenced. The results of this study will be submitted for formal publication within a peer-reviewed journal.

Trial registration number Prospectively registered on 16 October 2015 with the Australian New Zealand Clinical Trials Registry (ACTRN12615001088538). This study conforms to WHO Trial Registration Data Set.

  • In-transit
  • melanoma
  • metastases
  • topical
  • immunotherapy
  • clinical trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016816

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    Footnotes

    • Contributors TR (principal investigator): Manuscript writing, trial design, coordination, data collection and patient care. SW: Trial coordination, data collection and patient care. JT (trial coordinator): Trial coordination and data management. MW: Manuscript and protocol editing, trial design and patient care. HS: Trial design and manuscript editing. HPS: Trial design and coordination. BMS—Manuscript editing, trial design, coordination and patient care.

    • Funding TR was the recipient of a Junior Research Fellowship funded by the Queensland Government.

    • Competing interests TR was the recipient of a Junior Research Fellowship awarded by the Queensland Government and Clinical Research Fellowship awarded by the PA Research Foundation both of which supported the establishment of this study.

    • Patient consent Not applicable.

    • Ethics approval This study has Metro South Human Research Ethics Committee approval (HREC/15/QPAH/632) and is being conducted in accordance with appropriate human research standards using the TIDAL-M-01 Protocol Version 3.5.

    • Provenance and peer review Not commissioned; externally peer reviewed.