New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

This study is currently recruiting participants.
Verified October 2013 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
Akershus Dermatological Centre
Helse Stavanger HF
Oslo University Hospital
Førde Central Hospital
Haukeland University Hospital
Hudlegekontoret Lillehammer
Hudlegene på Holtet DA
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01482104
First received: November 17, 2011
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.

This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.

Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.


Condition Intervention
Skin Neoplasms
Carcinoma, Basal Cell
Drug: MAL-PDT re-treatment
Drug: usual MAL-PDT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • lesions response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Number of lesions in clinical complete response at follow-up


Estimated Enrollment: 277
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAL-PDT re-treatment
1 treatment of MAL-PDT with re-treatment of non-complete responders
Drug: MAL-PDT re-treatment
a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
Other Name: Methyl-aminolevulinate
Active Comparator: usual MAL-PDT
2 MAL-PDT treatments 1 week apart
Drug: usual MAL-PDT
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
Other Name: Methyl-aminolevulinate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male/female above 18 years of age
  • written informed consent
  • 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • Gorlin's syndrome
  • porphyria
  • xeroderma pigmentosum
  • history of arsenic exposure
  • known allergy to MAL
  • concomitant treatment with immunosuppressive medication
  • physical or mental conditions that most likely will prevent patients attending follow-up sessions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482104

Contacts
Contact: Eidi Christensen, PhD 0047 72822050 eidi.christensen@ntnu.no
Contact: Cato Mørk, PhD prof

Locations
Norway
Dept Dermatology, Haukeland University Hospital Recruiting
Bergen, Norway
Contact: I Bachmann         
Central Hospital Førde Recruiting
Førde, Norway
Contact: Ø Vatne         
Hudlegekontoret Lillehammer AS Recruiting
Lillehammer, Norway
Contact: L K Dotterud         
Akerskus Dermatological Centre Recruiting
Lørenskog, Norway
Contact: Cato Mørk, PhD         
Hudlegen på Holtet Recruiting
Oslo, Norway
Contact: A M Soler         
Dept Surgery, Oslo University Hospital Recruiting
Oslo, Norway
Contact: T Warloe         
Dept Dermatology, Oslo University Hospital Recruiting
Oslo, Norway
Contact: P Helsing         
Dept Dermato-Venereology, Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: S Kroon         
Department of Cancer Research and Molecular Medicine, NTNU Recruiting
Trondheim, Norway
Contact: Cato Mørk, PhD         
Contact: Eidi Christensen, PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
Akershus Dermatological Centre
Helse Stavanger HF
Oslo University Hospital
Førde Central Hospital
Haukeland University Hospital
Hudlegekontoret Lillehammer
Hudlegene på Holtet DA
Investigators
Study Director: Magne Børset, PhD prof Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01482104     History of Changes
Other Study ID Numbers: EC-004, 2011-004797-28
Study First Received: November 17, 2011
Last Updated: October 8, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Photochemotherapy
methyl 5-aminolevulinate

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014