Status:
TERMINATED
Study of a DNA Immunotherapy to Treat Melanoma
Lead Sponsor:
Scancell Ltd
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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 ≥ 5 x 10e9 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01138410
Start Date
May 1 2010
End Date
July 7 2017
Last Update
August 21 2017
Active Locations (5)
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1
Department of Medical Oncology, The Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
2
St James' Institute of Oncology
Leeds, United Kingdom, LS9 7TF
3
Christie Hospital
Manchester, United Kingdom, M20 4BX
4
Department of Clinical Oncology, City Hospital
Nottingham, United Kingdom, NG5 1PB