Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00868088
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2009-03-23
Brief Title:
Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma SCC of the Lip
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
A Clinical Trial of ALA Photodynamic Therapy for Treatment of Actinic Cheilitis in Patients With Squamous Cell Carcinoma of the Lip
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study is designed to evaluate the efficacy of photodynamic therapy PDT for treatment of actinic cheilitis AC and as an adjunct to Mohs surgery for squamous cell carcinoma SCC on the lips This study will utilize an FDA approved PDT modality DUSA Inc Wilmington MA 01887 using topical 5-amino-levulinic acid ALA for photosensitization followed by exposure to a Blu-U light source emitting 405-420nm wavelength light
Detailed Description:
BACKGROUND
SCC of the lip is commonly surrounded by extensive AC which may affect part or all of the lip vermillion While Mohs surgical technique with complete margin control is the preferred treatment for SCC at critical locations such as the lip this technique is complicated by surrounding AC AC and SCC in situ at the tumor edge make it difficult to achieve margins clear of dysplasia and as a result extra tissue beyond the invasive SCC often needs to be excised to ensure that the entire tumor is removed
Non-surgical treatments when used alone to treat SCC give lower cure rates than surgical removal and thus are not recommended as they place the subject at risk for recurrence and metastatic disease Although one study reported high SCC clearance rates with PDT alone 2425 SCCs histologically cleared recurrence of 2 SCCs occurred and a metastasis to a LN was seen in one patient Kubler et al
Given that PDT has been shown to have significant efficacy for actinic keratoses and actinic cheilitis but is inadequate as primary treatment of lip SCC we propose that PDT may be a useful adjunct to surgical resection allowing for less extensive surgery after the dysplasia is addressed with PDT and potentially a lower recurrence rate Although imiquimod and 5-FU are also used to treat cutaneous dysplasia many favor PDT treatment due to its greater tolerability shorter healing time and more predictable host response
There is significant data on the efficacy of PDT for treatment of actinic keratoses AKs and PDT is now FDA approved for treatment of AKs Piacquadio et al Data on PDT for treatment of AC is much more limited but small studies and case reports do indicate successful treatment of AC with regimens utilizing either topical 5-aminolevulinic acid 5-ALA or a similar compound methylaminopentanoate MAL The largest study with 5-ALA reports complete clinical clearance in 1319 patients treated with 1 to 3 treatments of ALA plus Pulsed-dye laser Alexiades Sotiriou et al report that with two PDT treatments 810 patients had complete clinical and histologic clearance Sotiriou Case reports indicate similar success Kodama Stender Efficacy has also been shown with MAL PDT One study found that with two sessions of MAL red light PDT complete histologic clinical clearance was seen in 715 cases of AC and partial clearance was seen in an additional 715 Berking et al Smaller studies and case reports have shown even higher response rates without clinical recurrence during short-term follow-up Rossi et al Hauschild et al We have chosen 5-ALA plus blue light for PDT treatment in this study because it is FDA approved for treatment of AKs and ALA is available in the United States
Specific Aims
1 To determine whether pre-operative treatment of the lips with ALA PDT can reduce the size of post-surgical defects scars in subjects with AC and lip SCC
2 To determine whether ALA PDT applied to the lips can effectively clear actinic cheilitis AC and SCC in-situ SCC-is of the lip
3 To assess the tolerability of ALA PDT for treatment of AC and SCC-is of the lips
SCC of the lip is commonly surrounded by extensive AC which may affect part or all of the lip vermillion While Mohs surgical technique with complete margin control is the preferred treatment for SCC at critical locations such as the lip this technique is complicated by surrounding AC AC and SCC in situ at the tumor edge make it difficult to achieve margins clear of dysplasia and as a result extra tissue beyond the invasive SCC often needs to be excised to ensure that the entire tumor is removed
Non-surgical treatments when used alone to treat SCC give lower cure rates than surgical removal and thus are not recommended as they place the subject at risk for recurrence and metastatic disease Although one study reported high SCC clearance rates with PDT alone 2425 SCCs histologically cleared recurrence of 2 SCCs occurred and a metastasis to a LN was seen in one patient Kubler et al
Given that PDT has been shown to have significant efficacy for actinic keratoses and actinic cheilitis but is inadequate as primary treatment of lip SCC we propose that PDT may be a useful adjunct to surgical resection allowing for less extensive surgery after the dysplasia is addressed with PDT and potentially a lower recurrence rate Although imiquimod and 5-FU are also used to treat cutaneous dysplasia many favor PDT treatment due to its greater tolerability shorter healing time and more predictable host response
There is significant data on the efficacy of PDT for treatment of actinic keratoses AKs and PDT is now FDA approved for treatment of AKs Piacquadio et al Data on PDT for treatment of AC is much more limited but small studies and case reports do indicate successful treatment of AC with regimens utilizing either topical 5-aminolevulinic acid 5-ALA or a similar compound methylaminopentanoate MAL The largest study with 5-ALA reports complete clinical clearance in 1319 patients treated with 1 to 3 treatments of ALA plus Pulsed-dye laser Alexiades Sotiriou et al report that with two PDT treatments 810 patients had complete clinical and histologic clearance Sotiriou Case reports indicate similar success Kodama Stender Efficacy has also been shown with MAL PDT One study found that with two sessions of MAL red light PDT complete histologic clinical clearance was seen in 715 cases of AC and partial clearance was seen in an additional 715 Berking et al Smaller studies and case reports have shown even higher response rates without clinical recurrence during short-term follow-up Rossi et al Hauschild et al We have chosen 5-ALA plus blue light for PDT treatment in this study because it is FDA approved for treatment of AKs and ALA is available in the United States
Specific Aims
1 To determine whether pre-operative treatment of the lips with ALA PDT can reduce the size of post-surgical defects scars in subjects with AC and lip SCC
2 To determine whether ALA PDT applied to the lips can effectively clear actinic cheilitis AC and SCC in-situ SCC-is of the lip
3 To assess the tolerability of ALA PDT for treatment of AC and SCC-is of the lips
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None