Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study

NCT03541252 | Completed Phase 1 Results DMC

• 1 other identifier: EudraCT2018-000141-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective clinical, uncontrolled, open-label, explorative phase IIa trial on patients with histologically- confirmed superficial and nodular basal cell carcinoma (BCC) . The study assesses tolerability and tumor clearance after laser-assisted topical delivery of two synergistic chemotherapeutic agents, cisplatin and 5-fluorouracil (5-FU) in BCC patients.

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

• Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE

  Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo/hyperpigmentation, infection in treated areas will be performed by a physician using a FDA-approved LSR scale at Days 1, 3-5, 14, 30 and 3 months after AFL exposure. Each parameter was graded on a standardized 5-point severity scale (0-4) representing none, mild, moderate, prominent, and severe. A total composite score reflecting overall LSR severity was then calculated based on the sum of all parameters (minimum score 0- least severe; max score: 24-most severe). lower scores are better.

  Days 1, 3-5, 14, 30 and 3 months post treatment

Secondary Outcomes (3)

• Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician

  Day 30 and Month 3 post treatment

• Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging

  Day 30 and 3 months post treatment

• Tumor Response- Histological Tumor Clearance Determined by Pathologist

  3 months post treatment

Study Arms (1)

Basal Cell Carcinoma Patients

EXPERIMENTAL

Patients (\>18 years) with histologically-verified superficial or nodular basal cell carcinoma (\<20 mm on the face/scalp, \<50mm on the trunk/extremities)

Drug: AFL-assisted cisplatin+5-FU

Interventions

AFL-assisted cisplatin+5-FU DRUG

Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30.

Basal Cell Carcinoma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
• \>18 years of age at baseline
• Legally competent, able to give verbal and written informed consent
• Subject in good general health, is willing to participate and can comply with protocol requirements.
• Fitzpatrick skin phototype I-III
• Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

You may not qualify if:

• High-risk BCC i. Tumors in the following anatomical locations: midface, orbital, ears ii. Size: \>20 mm in facial/scalp areas or \> 50 mm in non-facial/non-scalp areas iii. Subtype: morpheaform and micronodular BCC iv. History: Gorlin syndrome or immunosuppression
• Previous treatment of the BCC lesion
• Known allergy to cisplatin or Efudix®
• Other skin diseases present in the treatment area
• Tattoo in the treatment area which may interfere with or confound evaluation of the study
• History of keloids which is deemed clinically relevant in the opinion of the investigator
• Fitzpatrick skin phototype IV-VI
• Lactating or pregnant women

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Limitations and Caveats

Readers must be cognizant of the study's unblinded design, lack of conventional treatment control, limited sample size, short follow-up time, and use of punch biopsy rather than excision for histological clearance evaluation.

Results Point of Contact

• Title: Dr. Emily Wenande, MD, PhD
• Organization: Bispebjerg Hospital

emily.cathrine.wenande@regionh.dk

+4540505590

Study Officials

• Merete Haedersdal, MD, DMSc

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Senior Consultant, PhD, DMSc

Model Details: A prospective clinical, uncontrolled, open-label, explorative phase IIa trial

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 30, 2018
• Study Start: March 9, 2018
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: April 14, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-03

Locations

DK (1)