- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541252
Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study
Tolerability of Laser-assisted Cisplatin + 5-fluorouracil- an Exploratory Proof of Concept Study of Topical Combination Chemotherapy for Basal Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will receive ablative fractional laser (AFL)-assisted cisplatin+5-fluorouracil (5-FU) as a treatment for their cutaneous basal cell carcinoma (BCC). In brief, treatment areas consisting of tumors and a 5 mm margin will undergo AFL exposure (CO2 laser) followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) at a dose of 0.25 ml per cm2. After removal of cisplatin, a commercially distributed 5-FU cream (5% Efudix®) 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.
Outcome measures and methods/techniques are summarized below.
Primary outcome:
To investigate tolerability of topical AFL-assisted cisplatin+5-FU therapy for BCC by evaluating:
I. Severity and duration of clinical local skin reactions including erythema, edema, scabbing, flaking and pustulation assessed by a physician using an established 0-4 point scale (none, mild, moderate, severe) from 0-30 days post-treatment.
II. Occurrence of side effects (prolonged erythema/edema, hyper/hypopigmentation, scarring and infection) up to 3 months post-treatment.
Secondary outcome:
1) To monitor BCC tumor size and clearance based on clinical assessments and dermoscopy, supported by non-invasive imaging techniques including dynamic optical coherence tomography (D-OCT), reflectance confocal microscopy (RCM), high intensity focused ultrasound (HIFU) and histological analysis up to 3 months post-treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Hovedstaden
-
Copenhagen, Hovedstaden, Denmark, 2400
- Department of Dermatology, Bispebjerg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Basal Cell Carcinoma Patients
Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE
Time Frame: Days 1, 3-5, 14, 30 and 3 months post treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician
Time Frame: Day 30 and Month 3 post treatment
|
Tumor clearance (yes or no) will be evaluated clinically at Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.¨
|
Day 30 and Month 3 post treatment
|
Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging
Time Frame: Day 30 and 3 months post treatment
|
Clearance (yes or no) will be evaluated using non-invasive dynamic optical coherence tomography, high-intensity focused ultrasound and reflectance confocal microscopy imaging at Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.
|
Day 30 and 3 months post treatment
|
Tumor Response- Histological Tumor Clearance Determined by Pathologist
Time Frame: 3 months post treatment
|
Histological verification of tumor clearance will be performed 3 months after first treatment using tissue sections from a 4 mm punch biopsy. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines. NOTE: Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module since only 18 of the 19 patients consented to undergoing histologicla verification with biopsy. Those, presented data represents patients that underwent biopsy at the 3 month mark. |
3 months post treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merete Haedersdal, MD, DMSc, Bispebjerg Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EudraCT2018-000141-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Basal Cell
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | BCC | BCC - Basal Cell Carcinoma | Basal Cell CancerUnited States
-
MediWound LtdRecruitingNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
University of MiamiCompletedNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
Christopher ZacharyRecruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
University Hospital, BordeauxCompletedLocally Advanced Basal Cell Carcinoma | Metastatic Basal Cell CarcinomaFrance
-
Seton Healthcare FamilyUniversity of Texas at Austin; Dell Medical School at The University of Texas...WithdrawnBasal Cell Carcinoma (BCC) | Squamous Cell Carcinoma (SCC)
-
Biofrontera Bioscience GmbHActive, not recruitingSuperficial Basal Cell CarcinomaUnited States
-
Maastricht University Medical CenterRadboud University Medical Center; Catharina Ziekenhuis EindhovenCompletedSuperficial Basal Cell CarcinomaNetherlands
-
Maastricht University Medical CenterActive, not recruitingNodular Basal Cell CarcinomaNetherlands
-
Kavita SarinNational Institutes of Health (NIH); Medivir; American Skin AssociationCompletedSkin Basal Cell CarcinomaUnited States
Clinical Trials on AFL-assisted cisplatin+5-FU
-
Eastern Hepatobiliary Surgery HospitalCompletedHepatocellular CarcinomaChina
-
Taiho Oncology, Inc.Quintiles, Inc.Completed
-
SanofiCompleted
-
Shanghai Henlius BiotechRecruitingESCC or Esophageal Adenosquamous CarcinomaChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownSquamous Cell Carcinoma of the Head and NeckChina
-
City Clinical Oncology Hospital No 1Moscow Clinical Scientific Center; Moscow City Oncology Hospital No. 62Recruiting
-
University Medical Center GroningenAmsterdam UMC, location VUmcCompletedHead and Neck Squamous Cell CarcinomaNetherlands