Study of a DNA Immunotherapy to Treat Melanoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma|
- Safety & Tolerability [ Time Frame: Duration of treatment phase: up to 5.5 years ] [ Designated as safety issue: Yes ]Recording and assessment of adverse events to establish safety and tolerability of an investigational immunotherapy, SCIB1, in patients with melanoma whose cancer has spread from the initial tumour (i.e., stage III or stage IV melanoma).
- Safety, tolerability, biological and clinical effects [ Time Frame: Duration of treatment phase: up to 5.5 years ] [ Designated as safety issue: Yes ]
(i) Recording and assessment of adverse events and patient recorded experience to establish safety and tolerability of SCIB1 administered intramuscularly to melanoma patients using the TDS IM device.
(ii) Cellular immune response by ex vivo assay induced by SCIB1 administered intramuscularly to melanoma patients using the TDS-IM device.
(iii) Tumour response by CT scan in patients treated with SCIB1 (Part One only).
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.) at week 0, 3, 6, 12 and 24. Part 1 of the study will escalate through 0.4, 2.0, 4.0 and 8.0 mg dose level cohorts, each of three patients. In Part 2 of the study the 4.0 and 8.0 mg doses will be administered in the same regimen. At the discretion of the investigator, patients in both parts of the study may continue to receive SCIB1 at 3-6 month intervals for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138410
|Department of Mecical Oncology, The Royal Surrey County Hospoital|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|St James' Institute of Oncology|
|Leeds, United Kingdom, LS9 7TF|
|Manchester, United Kingdom, M20 4BX|
|Department of Clinical Oncology, City Hospital|
|Nottingham, United Kingdom, NG5 1PB|
|Department of Medical Oncology, Southampton General Hospital|
|Southampton, United Kingdom, SO16 6YD|
|Study Director:||Poulam M Patel, MD||Department of Clinical Oncology, City Hospital, Nottingham, UK|
|Principal Investigator:||Paul Lorigan, MD||Department of Medical Oncology, Christie Hospital, Manchester, UK|
|Principal Investigator:||Clive Mulatero, MD||St James' Institute of Oncology, Leeds, UK|
|Principal Investigator:||Christian Ottensmeier, MD||Department of Medical Oncology, Southampton General Hospital, UK|
|Principal Investigator:||Hardev Pandha, MD||Department of Medical Oncology, Royal Surrey County Hospital, Guildford, UK|