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Trial record 89 of 120 for:    focused ultrasound | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03541252
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: AFL-assisted cisplatin+5-FU Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective clinical, uncontrolled, open-label, explorative phase IIa trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerability of Laser-assisted Cisplatin + 5-fluorouracil― an Exploratory Proof of Concept Study of Topical Combination Chemotherapy for Basal Cell Carcinoma
Estimated Study Start Date : July 9, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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)
Drug: AFL-assisted cisplatin+5-FU
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.




Primary Outcome Measures :
  1. Change in Occurence of Local Skin Side Effects [ Time Frame: Baseline-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 0-4 point LSR scale at Days 1, 5, 14, 30 and 3 months after AFL exposure. Standardized, clinical photographs are taken to document skin reactions at each visit.


Secondary Outcome Measures :
  1. Tumor Response- Clinical [ Time Frame: baseline-3 months post treatment ]
    Tumor size (mm) and clearance (yes or no) will be evaluated clinically at baseline, Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.

  2. Tumor Response- Imaging [ Time Frame: baseline-3 months post treatment ]
    Tumor size (mm) and clearance (yes or no) will be evaluated using non-invasive dynamic optical coherence tomography, high-intensity focused ultrasound and reflectance confocal microscopy imaging at baseline, Day 30 and Month 3. If residual tumor is identified at 3 months follow-up, patients will receive conventional treatment according to national guidelines.

  3. Tumor Response- Histological Clearance [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
  2. >18 years of age at baseline
  3. Legally competent, able to give verbal and written informed consent
  4. Subject in good general health, is willing to participate and can comply with protocol requirements.
  5. Fitzpatrick skin phototype I-III
  6. Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

Exclusion Criteria:

  1. 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
  2. Previous treatment of the BCC lesion
  3. Known allergy to cisplatin or Efudix®
  4. Other skin diseases present in the treatment area
  5. Tattoo in the treatment area which may interfere with or confound evaluation of the study
  6. History of keloids which is deemed clinically relevant in the opinion of the investigator
  7. Fitzpatrick skin phototype IV-VI
  8. Lactating or pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541252


Contacts
Contact: Emily Wenande, MD +4540505590 emilycathrinew@hotmail.com

Locations
Denmark
Department of Dermatology, Bispebjerg Hospital Recruiting
Copenhagen, Hovedstaden, Denmark, 2400
Contact: Emily C Wenande, MD    +4540505590    emilycathrinew@hotmail.com   
Sponsors and Collaborators
Merete Haedersdal

Responsible Party: Merete Haedersdal, Professor, Senior Consultant, PhD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03541252     History of Changes
Other Study ID Numbers: EudraCT2018-000141-39
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Cisplatin
Antineoplastic Agents