Clinical trial NCT02550678: A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
Official title: A Phase 1/2a Study of the Efficacy and Safety of ASN-002 Alone or in Combination With 5-FU in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Basal Cell Nevus Syndrome
Skin Neoplasm
Nodular Basal Cell Carcinoma of Skin
Keywords: Untreated nBCC
Low-Risk
Lead sponsor: Ascend Biopharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal cell carcinoma (nBCC) in patients aged 18 years or over.

The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU for 3 weeks and undergo surgical excision of the tumor.

Detailed description: The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FU is safe and effective in the treatment of nodular basal cell carcinoma (nBCC).

Patients aged 18 or over, who have been diagnosed with nodular Basal Cell Carcinoma (nBCC), may be eligible to join this study.

Study details:

ASN-002 is an immunotherapeutic 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. Participants will attend the study centre weekly for an injection of ASN-002 alone of 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 tumor.

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 or in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Eligibility criteria: Inclusion Criteria:

1. Low risk nodular basal cell carcinoma
2. Biopsy of any other skin tumor
3. Willingness to have injection therapy followed by surgery
4. Written informed consent

Exclusion Criteria:

1. No or only minimal symptoms
2. Known or suspected metastatic disease.
3. Pregnant or Lactating females
4. Clinically active or uncontrolled skin disease
5. Immunocompromised or receiving immunomodulating agent
6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months
7. Any serious or active medical or psychiatric illness
8. Recreational or therapeutic drug or alcohol use
9. Taking any investigational product within 1 month of first dose of ASN- 002.

Primary outcomes:
measure: Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC
timeFrame: Participants will be followed up for up to 6 months.
Secondary outcomes:
measure: Microscopic clearance of the injected basal cell carcinoma.
timeFrame: Microscopic examinations of sample collected at 17weeks after the first dose.
measure: Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU
timeFrame: Change in nBCC will be assessed for up to 6 months from the first treatment visit.
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Siller Medical T/A Central Brisbane Dermatology
state: Queensland
city: Brisbane
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
Study officials:
affiliation: Veracity Clinical Research Pty Ltd.
name: Lynda Spelman
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinclair Dermatology Pty Ltd
name: Rodney Sinclair
role: PRINCIPAL_INVESTIGATOR
affiliation: Siller Medical T/A Central Brisbane Dermatology
name: Gregory Siller
role: PRINCIPAL_INVESTIGATOR
References: