Study of a DNA Immunotherapy to Treat Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Scancell Ltd
Sponsor:
Information provided by (Responsible Party):
Scancell Ltd
ClinicalTrials.gov Identifier:
NCT01138410
First received: May 24, 2010
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Biological: SCIB1
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Scancell Ltd:

Primary Outcome Measures:
  • Safety & Tolerability [ Time Frame: Duration of treatment phase: up to 5.5 years ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Safety, tolerability, biological and clinical effects [ Time Frame: Duration of treatment phase: up to 5.5 years ] [ Designated as safety issue: 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).



Estimated Enrollment: 54
Study Start Date: May 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138410

Contacts
Contact: Poulam M Patel, MD +44 115 8231850 poulam.patel@nottingham.ac.uk

Locations
United Kingdom
St James' Institute of Oncology Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Clive Mulatero, MD    +44 113 2068650      
Principal Investigator: Clive Mulatero, MD         
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Kellie Yu    +44 161 918 7444      
Principal Investigator: Paul Lorigan, MD         
Department of Clinical Oncology, City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Poulam M Patel, MD    +44 115 8231850    poulam.patel@nottingham.ac.uk   
Principal Investigator: Poulam M Patel, MD         
Department of Medical Oncology, Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Christian H Ottensmeier, MD    +44 (0)2380 795161      
Principal Investigator: Christian H Ottensmeier, MD         
Sponsors and Collaborators
Scancell Ltd
Investigators
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: Clive Mulatero, MD St James' Institute of Oncology, Leeds, UK
Principal Investigator: Christian Ottensmeier, MD Department of Medical Oncology, Southampton General Hospital, UK
  More Information

No publications provided

Responsible Party: Scancell Ltd
ClinicalTrials.gov Identifier: NCT01138410     History of Changes
Other Study ID Numbers: SCIB1-001
Study First Received: May 24, 2010
Last Updated: October 9, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Scancell Ltd:
Immunotherapy
Melanoma
Gene therapy
DNA plasmid
Cancer vaccine
Electroporation
CTL response

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 26, 2014