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Health Condition(s) or Problem
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Malignant Melanoma
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
Part One only:
- 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 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.
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Who cannot enter the trial
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Inclusion Criteria:
Part One only:
- 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 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.
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What will happen
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Biological; SCIB1; 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 MTD determined 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.; SCIB1
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Primary aim
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Safety & Tolerability
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Secondary Aim
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Safety, tolerability, biological and clinical effects; Duration of treatment phase: up to 5.5 years; 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).
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Leeds, Manchester, Newcastle upon Tyne, Nottingham, Southampton
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