Basal Cell CarcinomaPhase 3NCT00473343
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma
A Phase 3 study testing Metvix® cream in people with Basal Cell Carcinoma, run by Galderma R&D at 7 sites in Australia.
Trial summary
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Metvix® cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesAustralia
- Study dates
- Sep 2000to Jun 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
- Males or females above 18 years of age.
- Written informed consent. AND
- Participants with high risk of surgical complications due to:
- Anticoagulant medication or bleeding disorders
- Cardiac risk factors
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- Anaesthetic contraindications
- Poor surgical compliance because of participant refusal, dementia, or inability to perform wound care.
- OR
- Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:
- A large BCC lesion with the largest diameter:
- Equal to or greater than 15 mm on extremities, except below the knees, where largest diameter should be equal to or greater than 10 mm
- Equal to or greater than 20 mm on the trunk
- Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone according to Swanson) or on the ear In participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.
Who cannot join
- Prior treatment of the lesion within 4 weeks.
- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
- Participant with porphyria.
- Pigmented lesions.
- Known allergy to Metvix® or a similar compound.
- Participation in another clinical study either concurrently or within the last 30 days
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- Participant with Gorlin's syndrome.
- Participant with Xeroderma pigmentosum
- Pregnant or breast-feeding (all women of child-bearing potential must document a negative pregnancy test and use contraception during the treatments and for at least one month thereafter).
- Conditions associated with a risk of poor protocol compliance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Department of Dermatology, Royal Adelaide Hospital
Adelaide, South Australia, SA 5000
Dermatology Department, The Queen Elisabeth Hospital
Adelaide, South Australia, SA 5011
South East Dermatology, The Belmont Specialist Clinic
Carnia, Queensland, 4152
Fremantle Dermatology
Fremantle, Western Australia, WA 6106
Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre
Heidelberg, Victoria, VIC 3081
Department of Dermatology, St. George Hospital
Kogarah, New South Wales, NSW 2217
Dermatology Surgery & Laser Centre, The Perth Surgicentre
Perth, Western Australia, WA 6151
About this study
Official title: An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, there has been an increasing interest in using precursors of the endogenous photoactive porphyrins. The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
Read more
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.
In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.
Read the detailed description
Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).
The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).
- Conditions
- Basal Cell Carcinoma
- Being tested
- Metvix® cream
- Keywords
- Photodynamic therapy (PDT), PDT with Metvix cream, "High risk" BCC, Basal Cell carcinoma, Histologically confirmed complete response
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix® creamDrug
Also called Methyl 5-aminolevulinate hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Metvix® PDT | Experimental | Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. Receives: Drug: Metvix® cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
Measured: 3 months after last Metvix PDT cycle, up to 6 months
Secondary outcomes (5)
Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
Complete response was defined as no clinically visible BCC lesions in the treatment area.
Measured: 3 months after last Metvix PDT cycle, up to 6 months
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
- excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin
- good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin
- fair: slight to moderate occurrence of scarring, atrophy or induration
- poor: extensive occurrence of scarring, atrophy or induration.
Measured: 3 months after the last metvix PDT cycle, up to 6 months
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as:
excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
Measured: 3 months after the last metvix PDT cycle, up to 6 months
Recurrence Rate in Complete Clearance Group
Recurrence rate in complete clearance(CC) group was analyzed.
Measured: 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
Measured: 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startSep 2000
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl Vinciullo, MD, Principal investigator, Dermatology Surgery & Laser Centre, Perth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473343
- Sponsor's protocol ID
- PC T310/00
- Status last verified
- Jun 2021
- First submitted
- 14 May 2007
- Last updated
- 5 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00473343
- Acronym / sponsor ID
- PC T310/00
- Conditions
- Basal Cell Carcinoma
- Keywords
- Photodynamic therapy (PDT), PDT with Metvix cream, "High risk" BCC, Basal Cell carcinoma, Histologically confirmed complete response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2000 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, there has been an increasing interest in using precursors of the endogenous photoactive porphyrins. The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.
In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.
Detailed description
Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).
The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metvix® PDT | Experimental | Drug: Metvix® creamParticipants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
- Males or females above 18 years of age.
- Written informed consent. AND
- Anticoagulant medication or bleeding disorders
- Cardiac risk factors
Key exclusion criteria (10 listed)
- Prior treatment of the lesion within 4 weeks.
- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
- Participant with porphyria.
- Pigmented lesions.
- Known allergy to Metvix® or a similar compound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metvix® creamAlso: Methyl 5-aminolevulinate hydrochloride | Drug | Metvix® PDT |
Primary outcome
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
Time frame: 3 months after last Metvix PDT cycle, up to 6 months
Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
5 secondary outcomes
Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
Time frame: 3 months after last Metvix PDT cycle, up to 6 months
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Time frame: 3 months after the last metvix PDT cycle, up to 6 months
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Time frame: 3 months after the last metvix PDT cycle, up to 6 months
Recurrence Rate in Complete Clearance Group
Time frame: 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Time frame: 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Vinciullo, MD principal investigator
Dermatology Surgery & Laser Centre, Perth
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metvix® cream in people with Basal Cell Carcinoma, run by Galderma R&D at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle (time frame: 3 months after last Metvix PDT cycle, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.