29 September 2015
Nodular Basal Cell Carcinoma, Basal Cell Carcinoma Nevus Syndrome
Recruitment site location(s) (State)
Active, not recruiting
Anticipated date of first participant enrolment
15 September 2015
Ethics application status
The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FUis safe and effective in the treatment of nodular basal cell carcinoma (nBCC).
Who is it for?
You may be eligible to join this study if you are aged 18 or over, have been diagnosed with nBCC.
ASN-002 is a vaccine-like product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body’s own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. 5-FU is a chemotherapeutic agent approved to treat many types of cancer. Participants will attend the study centre weekly for an injection of ASN-002 alone or in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumour.
Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study.
It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone and in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.