Study of a DNA Immunotherapy to Treat Melanoma
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ClinicalTrials.gov Identifier: NCT01138410 |
Recruitment Status :
Terminated
(Product availability)
First Posted : June 7, 2010
Last Update Posted : August 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Melanoma | Biological: SCIB1 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Actual Study Start Date : | May 2010 |
Actual Primary Completion Date : | July 7, 2017 |
Actual Study Completion Date : | July 7, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: SCIB1 |
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 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. |
- Safety & Tolerability [ Time Frame: Duration of treatment phase: up to 5.5 years ]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 ]
(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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ≥ 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138410
United Kingdom | |
Department of Medical Oncology, The Royal Surrey County Hospital | |
Guildford, Surrey, United Kingdom, GU2 7XX | |
St James' Institute of Oncology | |
Leeds, United Kingdom, LS9 7TF | |
Christie Hospital | |
Manchester, United Kingdom, M20 4BX | |
Department of Clinical Oncology, City Hospital | |
Nottingham, United Kingdom, NG5 1PB | |
Department of Medical Oncology, Southampton General Hospital | |
Southampton, United Kingdom, SO16 6YD |
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: | Maria Marples, MD | St James' Institute of Oncology, Leeds, UK | |
Principal Investigator: | Christian Ottensmeier, MD | Department of Medical Oncology, Southampton General Hospital, UK | |
Principal Investigator: | Hardev Pandha, MD | Department of Medical Oncology, Royal Surrey County Hospital, Guildford, UK |
Responsible Party: | Scancell Ltd |
ClinicalTrials.gov Identifier: | NCT01138410 History of Changes |
Other Study ID Numbers: |
SCIB1-001 |
First Posted: | June 7, 2010 Key Record Dates |
Last Update Posted: | August 21, 2017 |
Last Verified: | August 2017 |
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