None listed
Conditions
Brief summary
This study aims to test the safety of multiple injections of the Dz13 (combined with DOPE and DOTAP) drug in patients with melanoma skin cancer. Dz13 is a small piece of DNA which binds to an mRNA molecule c-Jun and cuts it into two pieces disrupting the production of the c-Jun protein and can lead to a reduction in growth and spread of the tumour. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with dermal in-transit or satellite metastatic melanoma. You should have at least 3 measurable lesions at minimum distance of 5 cm from each other. Trial details: There will be 4 different cohorts (or groups) in this study, who are enrolled consecutively. Participants in the first group will receive 2 injections of the drug Dz13 into their tumour over a period of 1 week. Participants in the second group will receive twice weekly injections of Dz13 for two weeks, and group three for three weeks. Based on the findings of the first three groups, the fourth group will then receive twice weekly Dz13 injections for two or three weeks. All participants will be regularly assessed to determine safety and tolerability of treatment. The treated and pre-seelcted untreated tumours will be assessed by investigating the c-Jun levels within the tumour tissue and measuring tumour size. It is thought that Dz13 treatment may reduce the size of melanoma tumours in humans without significant toxicity.
Interventions
Dz13 DNAzyme (100 mcg) complexed with lipids DOPE and DOTAP administered as single intra-tumoural injection twice weekly to cohort 1(total dose 200 mcg) for one week cycle, to cohort 2 for two weeks (total dose 400 mcg) and to cohort 3 for three weeks (total dose 600 mcg as the dose finding Part 1. Part 2 fourth expanded cohort will receive Dz13 DNAzyme (100 mcg) complexed with lipids DOPE and DOTAP administered as single intra-tumoural injection twice weekly for two or three week cycles. Select
Dz13 DNAzyme (100 mcg) complexed with lipids DOPE and DOTAP administered as single intra-tumoural injection twice weekly to cohort 1(total dose 200 mcg) for one week cycle, to cohort 2 for two weeks (total dose 400 mcg) and to cohort 3 for three weeks (total dose 600 mcg as the dose finding Part 1. Part 2 fourth expanded cohort will receive Dz13 DNAzyme (100 mcg) complexed with lipids DOPE and DOTAP administered as single intra-tumoural injection twice weekly for two or three week cycles. Selection of two or three week treatment duration will be dependent on the following conditions as assessed from cohorts 2 and 3 in Part 1: 1. acceptable saftey profile following review of all safety data by a Data Safety Monitoring Board (DSMB) and pharmacokinetic (PK) analysis 2. evidence of c-Jun (Dz13 treatment target gene) suppression in tumour tissue and/or evidence of tumour response change in tumour size
Sponsors
The University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosed dermal in-transit or satellite metastatic melanoma with at least 3 measurable lesions at minimum distance of 5 cm from each other ECOG performance status 0-1 Acceptable haematologic, coagulation, renal and hepatic function
Exclusion criteria
Metastatic/in-transit or satellite lesions located on face, head and neck Women of child bearing age Prior or co-existing malignancy Radiotherapy to >30% bone marrow in previous 3 months Clinically significant non-malignant disease Current immunosuppression History of immune-mediated throbocytopenia or other platelet disease Enrolment in another clinical study involving any other investigational agent
Outcome results
None listed