Clinical Trial

 

A phase I study of the Dz13 drug targeting the c-Jun gene in subjects with skin cance (nodular Basal Cell Carcinoma). | DISCOVER



This refers to the main intervention being tested in the study.
Treatment: an intervention used to treat cancer such as hormones, chemotherapy, targeted and biological therapies, radiotherapy or surgery.
Prevention/screening: evaluate a test or treatment used to prevent cancer from developing or from progressing to cause symptoms or death eg a screening test, for example mammograms to prevent death from breast cancer.
Diagnosis: evaluate interventions used to identify cancer.
Psychosocial: interventions or techniques that involve counseling, training, communication or educational based programs.
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Rehabilitation: interventions to restore or improve physical abilities lost from cancer.
Antiemetics: Trials investigating the outcomes from the use of antiemetics (anti-nausea medication).
Complementary: Complementary therapies complement conventional medical treatment. Complementary medicines can include herbal, vitamin, mineral, homoeopathic, nutritional and other supplements. Therapies include herbal medicine, Chinese medicine, chiropractic, naturopathy, osteopathy, acupuncture, homoeopathy, reflexology, aromatherapy, Alexander technique, Bach and other flower remedies, massage, hypnotherapy, shiatsu, ayurvedic medicine, nutritional medicine, yoga, anthroposophical medicine, spiritual healing, iridology, kinesiology, meditation and others.
Palliative care: Interventions used to control symptoms and improve quality of life.
Focus of Trial
Treatment: Targeted and biological therapies





The purpose of this study is to test the safety of a new treatment (Dz13 combined with DOPE and DOTAP) for nodular BCC, a form of skin cancer.
Dz13 is a small piece of DNA which binds to an mRNA molecule in the cell which in turn produces a specific protein known as c-Jun. The c-Jun gene is known to be abnormally active in many types of cancer cells, including BCC, causing the abnormal production of the c-Jun protein molecule. The c-Jun protein is involved in 'switiching on' other genes involved in cell growth, resulting in growth and spread of tumour cells. Dz13 binds to the c-Jun mRNA and chops it into two pieces, which disrupts production of the c-Jun protein and limits the growth and spread of the tumour. c-Jun is present at very low levels in normal adult tissues and is mostly expressed at high levels in tumour tissue. It is hypothesised that Dz13 will be able to stop the growth and spread of BCC and other skin tumours without significant toxicity. Dz13 has been shown in animal studies to be well tolerated at doses 35-fold higher than the highest dose that will be used in this study.


Description of the Control
No control treatment

Description of the Intervention
Dz13 DNAzyme complexed with the lipids DOPE and DOTAP administered as a single intratumoural injection. Three dose cohorts of 10 mcg, 30 mcg and 100 mcg Dz13.

Allocation to Intervention
Nonrandomised trial


To determine the safety and tolerability of Dz13 complexed with DOPE/DOTAP administered as a single intra-tumoural injection as determined by adverse events (AEs), changes in vital signs, clinical laboratory tests and 12-lead electrcardiography (ECG).
1, 2, 4, 8, 12, 24 hours, 7 days, 14 days, 28 days post injection.

To determine the maximum tolerated dose of Dz13 complexed with DOPE/DOTAP administered as a single intra-tumoural injection as assessed by the incidence of dose limiting toxicity (DLT) events in each dose cohort.
1, 2, 4, 8, 12, 24 hours, 7 days, 14 days, 28 days post injection.


To measure the level of Dz13 in serum following administration of a single dose of Dz13 complexed with DOPE/DOTAP via intra-tumoural injection.
30 min, 1, 2, 4, 8, 12, 24 hours, 7 days, 14 days, 28 days post injection.

To compare BCC histopathology and immunohistochemistry 14 days following Dz13 administration relative to baseline.
14 days post injection.


Intervention arm: mild transient (less than 24 hours) injection site swelling, nausea and discomfort in one subject. No serious adverse events occurred in any of the nine subjects

Histologically proven nodular BCC.
Measurable disease of 8-16 mm located on trunk or limbs.
Presence of dividing cells as identified histologically.

Minimum Age:
18 Years

Maximum Age:
No limit

Gender:
Both males and females

Women of childbearing potential.
Prior or co-existing malignancy.
Radiotherapy to >30% bone marrow in previous three months.
Known genetic predisposition to skin cancer.
Clinically significant non-malignant disease.
Current immunosuppression.
History of immune-mediated thrombocytopenia or other platelet disease.
History of drug abuse.
Enrollment in another clinical study using another investigational agent.

Similar cost as usual care
More time commitment than usual care
Additional travel commitments




Government body
Cancer Institute NSW
Australian Technology Park
Biomedical Building
Suite 101
1 Central Avenue
EVELEIGH NSW 2015
Australia


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