Study of a DNA Immunotherapy to Treat Melanoma
The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.
|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.
|Contact: Poulam M Patel, MD||+44 115 email@example.com|
|St James' Institute of Oncology||Recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Contact: Clive Mulatero, MD +44 113 2068650|
|Principal Investigator: Clive Mulatero, MD|
|Manchester, United Kingdom, M20 4BX|
|Contact: Kellie Yu +44 161 918 7444|
|Principal Investigator: Paul Lorigan, MD|
|Department of Clinical Oncology, City Hospital||Recruiting|
|Nottingham, United Kingdom, NG5 1PB|
|Contact: Poulam M Patel, MD +44 115 8231850 firstname.lastname@example.org|
|Principal Investigator: Poulam M Patel, MD|
|Department of Medical Oncology, Southampton General Hospital||Recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Contact: Christian H Ottensmeier, MD +44 (0)2380 795161|
|Principal Investigator: Christian H Ottensmeier, MD|
|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|