Contact information
Type
Scientific
Primary contact
Dr Hamm-Ming Sheu
ORCID ID
Contact details
No. 138
Sheng-Li Road
Department of Dermatology
National Cheng Kung University Hospital
Tainan
704
Taiwan
hmsheu@mail.ncku.edu.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCCD06003A
Study information
Scientific title
An open phase II study to assess the efficacy and safety of topical SR-T100® gel in the treatment of human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease)
Acronym
Study hypothesis
In our preliminary animal study to evaluate the efficacy and toxicity of topical SR-T100® gel, using an approved protocol of ultraviolet B (UVB)-induced hairless mouse (HRS) cutaneous cell carcinoma, 35 of 40 squamous cell carcinomas (SCCs) disappeared within 10 weeks of treatment (once-daily). Besides the high complete response rate (87.5%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100® gel.
We hypothesise that SR-T100® gel can be a potential alternative treatment for cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease).
Ethics approval
Human Experiment and Ethics Committee of National Cheng Kung University Hospital approved on the 20th July 2007 (ref: HR-94-72).
Study design
Single centre phase II open-label study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowens disease)
Intervention
Only one lesion will be selected for treatment and assessment in each patient. SR-T100® gel will be applied once daily on the targeted lesion and covered with an occlusive dressing. Patients will be instructed to apply the study gel to the entire area of target lesion including its peripheral normal skin approximately 1 cm around the tumour. Treatment will be continued until tumour is clinically cleared or until 16 weeks of treatment completed. The 16 week treatment is chosen on the basis of maximum duration treatment of topical drug on actinic keratosis and Bowen's disease previously reported.
Intervention type
Drug
Phase
Phase II
Drug names
SR-T100® gel
Primary outcome measures
To assess the response rate of SR-T100® in patients with cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease), defined as the proportion of patients whose lesion size (length x width x height) is reduced greater than 75%. Measured until tumour is clinically cleared or until 16 weeks of treatment completed.
Secondary outcome measures
1. Complete clearance rate, defined as the proportion of patients with no clinically visible actinic keratosis and Bowen's disease lesions in the treatment area
2. Partial clearance rate, defined as the proportion of patients with at least a 75% reduction of actinic keratosis and Bowen's disease lesion size (length x width x height) in the treatment area
3. Histological response rate: proportion of patients with biopsy proven clearance of cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease)
4. The safety profile of SR-T100® gel
Measured until tumour is clinically cleared or until 16 weeks of treatment completed.
Overall trial start date
01/12/2007
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients must meet ALL of the inclusion criteria for the entry of this study:
1. Male or female; aged greater than or equal to 20 years old
2. Patients must have histologically confirmed squamous cell carcinoma in situ (actinic keratosis or Bowen's Disease) for the target lesion
3. Patients must have a measureable lesion 5 mm or larger for actinic keratosis of 10 mm or larger for Bowen's disease
4. Patients must have a performance of less than or equal to 2 (Eastern Cooperative Oncology Group [ECOG])
5. Patients who have signed an approved written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 patients for actinic keratosis and 15 patients for Bowen's disease
Participant exclusion criteria
Patients will be excluded from this study for ANY of the following reasons:
1. Patients with histologic subtypes other than squamous cell carcinoma in situ (actinic keratosis or Bowen's disease)
2. Patients with tumour extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum
3. Patients who have grossly suspicious or inflamed nodes on physical examination
4. Patients with grossly infected tumours
5. Patients with recurrent invasive squamous cell carcinoma
6. Patients with a history of other invasive malignancies, if there is any evidence of the other malignancy being present within the past 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
7. Use of any investigational drug in the 30 days before screening
8. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods
Recruitment start date
01/12/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Taiwan
Trial participating centre
No. 138, Sheng-Li Road
Tainan
704
Taiwan
Sponsor information
Organisation
G&E Herbal Biotech (Taiwan)
Sponsor details
No.26
Lane 31
Sec. 1
HuanDong Rd.
Tainan Science Park
ShnShih Township
Tainan County
744
Taiwan
+886 (0)6 505 2976
kwkuo@geherbs.com.tw
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
G&E Herbal Biotech (Taiwan) (ref: RDP009)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Industrial Technology, Ministry of Economic Affairs (Taiwan) (ref: 97-EC-17-A-20-I1-0003)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary