Study of a DNA Immunotherapy to Treat Melanoma | Not Recruiting
Study of a DNA Immunotherapy to Tre... | Not Recruiting
Study of a DNA Immunotherapy to Treat Melanoma

Trial Source

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Medical Conditions
  • Malignant Melanoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01138410
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : SCIB1

Study Arm Groups : SCIB1

Intervention Type
See Interventions above
Primary Outcome Measures
    Safety & Tolerability; Duration of treatment phase: up to 5.5 years
Secondary Outcome Measures
    Safety, tolerability, biological and clinical effects; Duration of treatment phase: up to 5.5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    Part One and Part Two (8.0 mg dose):

    - Histologically confirmed Stage IV or Stage III malignant melanoma, as defined by the American Joint Committee on Cancer (AJCC).

    - Must have measurable disease (RECIST 1.0)

    Part Two (4.0 mg dose) only:

    - Histologically confirmed, resected Stage III or resected Stage IV malignant melanoma, as defined by the AJCC, within 12 months of resection and with no tumour detectable at the time of screening.

    Part One and Part Two:

    - HLA-A2 positive.

    - Positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.

    - Lymphocyte count ≥ 500,000 cells/mL.

    - Serum lactate dehydrogenase (LDH) ≤ upper limit of normal.

    - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

    - Willing and able to give written, informed consent.

    - If male or female of childbearing potential, must be willing to use an effective contraceptive during the course of the study and for three months afterwards.

    Exclusion Criteria:

    - Known brain metastases at screening.

    - Life expectancy of less than three months.

    - Patients with TNM classification M1c at screening.

    - Prior systemic anti-cancer treatment within four weeks of screening.

    - Prior treatment with systemic corticosteroids or other immunosuppressants within four weeks of screening.

    - Previous (within five years) or current malignancy at other sites with the exception of curatively treated local tumours such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin.

    - Pregnant or lactating women.

    - Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments. Caution should be used for patients with suspected or diagnosed epilepsy.

    - Any electronic stimulation device such as cardiac demand pacemaker, automatic implantable cardiac defibrillator, nerve stimulators or deep brain stimulators.

    - Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage) exceeds 40 mm.

    - Individuals with a heart rate of ≤ 50 beats per minute, history of significant cardiac abnormality and/or significant abnormal baseline electrocardiogram (ECG) readout.

    - Treatment with any investigational product within the four weeks preceding screening.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Nottingham
Nottinghamshire
NG5 1PB
Guildford
GU2 7XX
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
SCIB1-001
Sponsor(s)
Scancell Ltd
Key Dates

Recruitment Start Date

May 2010

Recruitment End Date

Dec 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

24 May 2010

Last Updated

12 Apr 2016