New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
This study is currently recruiting participants.
Verified August 2012 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
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: August 20, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Aminolevulinic acid
Aminolevulinic acid hydrochloride
Methyl aminolevulinate
U.S. FDA Resources
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: | August 20, 2012 |
| 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 June 18, 2013