Reduction of the size of a wide spread white skin cancer with an oncolytic virus before surgery

Phase 1

• Conditions: Basal cell carcinoma (BCC) is the most common malignant neoplasm in fair skinned humans (Rubin et al., 2005). Over the last decades its incidence has increased (Chinem and Miot, 2011). Especially when it comes to BCCs of intermediate size, a surgical approach, while still feasible is often associated with complications and often requires major reconstructive surgery with a suboptimal cosmetic outcome. We hypothesize that neoadjuvant Talimogene laherparepvec minimizes the size of the BCC.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002165-19-AT
• Lead Sponsor: Medical University Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1)Subject has provided informed consent prior to initiation of any study-specific activities/procedures
2)Male or female age = 18 years at the time of informed consent
3)BCC, excluding superficial and sclerodermiform BCC either newly developed or recurring/progressing after prior treatment; In clinically suspected BCCs, without a prior histopathological confirmation, the confirmation with the baseline biopsy is sufficient
4)Subjects have to be willing to undergo a tumor biopsy at baseline
5)The tumor has to be assessed by an expert panel (see section 8.1.1.) as being locally advanced but resectable if reconstructive plastic surgery (i.e. flap or skin graft) is used for wound closure
6)Tumors must be measurable by caliper
7)ECOG Performance Status 0
8)Adequate hematological, renal, hepatic and coagulation function within 14 days prior to enrollment
9)Any systemic therapy for advanced BCC must have been stopped at least 8 weeks before study treatment and patients must have recovered from any acute toxicity associated with prior therapy
10)Life expectancy of more than three months
11)Female Subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to enrollment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1)Metastatic BCC
2)History of any other malignancy within the past 3 years with the following exceptions:
•Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•Adequately treated cervical carcinoma in situ without evidence of disease
•Adequately treated breast ductal carcinoma in situ without evidence of disease
•Prostatic intraepithelial neoplasia without evidence of prostate cancer
•Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
3)Active infection (herpetic skin lesions, or prior complications of herpetic infection, HIV, Hep A, B, C)
4)Previous treatment with T-VEC or any other oncolytic virus
5)Prior therapy with tumor vaccines, chemotherapy, radiotherapy, biological cancer therapy, targeted therapy < 28 days prior to enrollment
6)Any concurrent medical condition requiring the use of systemic steroids or antiviral drugs
7)History or evidence of active autoimmune disease that requires systemic treatment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
8)Evidence of clinically significant immunosuppression
9)Any underlying medical condition which, in the Investigator's opinion, will make the administration of study drugs hazardous or obscure the interpretation of Adverse Events
10)Female Subjects who are pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of T-VEC
11)Sexually active Subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with T-VEC
12)Female Subjects of childbearing potential who are unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of T-VEC
13) Live vaccines within 28 days prior to enrollment
14) Major surgery prior to enrollment 28 days prior to enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified