Non-melanomatous Skin CancerEarly Phase 1NCT00663910
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
A Early Phase 1 study testing Aminolevulinic Acid, biopsy and diagnostic imaging technique in people with Non-melanomatous Skin Cancer, run by The Cleveland Clinic.
Trial summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- Aminolevulinic Acid, biopsy and diagnostic imaging technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Oct 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm
- No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to aminolevulinic acid or any component of this medication
PRIOR CONCURRENT THERAPY:
- Concurrent immunosuppressive or chemotherapeutic medications allowed
- Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed
- Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed
- Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed
- No concurrent participation in another clinical trial
- No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers
- No concurrent medical therapy or radiotherapy for other cancers
About this study
Official title: Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy.
PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
Read the detailed description
OBJECTIVES:
- To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration.
- To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods.
- To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors.
- To establish a skin cancer tissue bank.
OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- Aminolevulinic Acid, biopsy, diagnostic imaging technique, therapeutic conventional surgery
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic AcidDrug
Also called ALA
On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.
biopsyProcedure or surgery
Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.
diagnostic imaging techniqueProcedure or surgery
Also called Aurora dosimeter
Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
therapeutic conventional surgeryProcedure or surgery
The non-melanoma skin cancer will be excised using the MOHS procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration
Measured: Day 1
Secondary outcomes (3)
In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods
Measured: Day 1
Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors
Measured: Day 1
Establishment of a skin cancer tissue bank
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward V. Maytin, MD, PhD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663910
- Sponsor's protocol ID
- CASE-9Z07-CC417
- Other IDs
- P30CA043703, P01CA084203, CC417
- Status last verified
- Dec 2016
- First submitted
- 19 Apr 2008
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
- ClinicalTrials.gov ID
- NCT00663910
- Acronym / sponsor ID
- CASE-9Z07-CC417
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy.
PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
Detailed description
OBJECTIVES:
- To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration.
- To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods.
- To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors.
- To establish a skin cancer tissue bank.
OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Aminolevulinic AcidAlso: ALAOn Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®. | Drug | – |
| biopsyThen local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat. | Procedure or surgery | – |
| diagnostic imaging techniqueAlso: Aurora dosimeterTwo hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter. | Procedure or surgery | – |
| therapeutic conventional surgeryThe non-melanoma skin cancer will be excised using the MOHS procedure. | Procedure or surgery | – |
Primary outcome
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration
Time frame: Day 1
3 secondary outcomes
In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods
Time frame: Day 1
Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors
Time frame: Day 1
Establishment of a skin cancer tissue bank
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: No. IPD will not be shared.
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.
Edward V. Maytin, MD, PhD study chair
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aminolevulinic Acid, biopsy and diagnostic imaging technique in people with Non-melanomatous Skin Cancer, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.). Results are not available in the source record.
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?
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration (time frame: Day 1). 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 2 Jan 2017.