⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Study of a DNA Immunotherapy to Treat Melanoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Study of a DNA Immunotherapy to Treat Melanoma

Official Title: A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

Study ID: NCT01138410

Interventions

SCIB1

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Medical Oncology, The Royal Surrey County Hospital, Guildford, Surrey, United Kingdom

St James' Institute of Oncology, Leeds, , United Kingdom

Christie Hospital, Manchester, , United Kingdom

Department of Clinical Oncology, City Hospital, Nottingham, , United Kingdom

Department of Medical Oncology, Southampton General Hospital, Southampton, , United Kingdom

Contact Details

Name: Poulam M Patel, MD

Affiliation: Department of Clinical Oncology, City Hospital, Nottingham, UK

Role: STUDY_DIRECTOR

Name: Paul Lorigan, MD

Affiliation: Department of Medical Oncology, Christie Hospital, Manchester, UK

Role: PRINCIPAL_INVESTIGATOR

Name: Maria Marples, MD

Affiliation: St James' Institute of Oncology, Leeds, UK

Role: PRINCIPAL_INVESTIGATOR

Name: Christian Ottensmeier, MD

Affiliation: Department of Medical Oncology, Southampton General Hospital, UK

Role: PRINCIPAL_INVESTIGATOR

Name: Hardev Pandha, MD

Affiliation: Department of Medical Oncology, Royal Surrey County Hospital, Guildford, UK

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: