Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103246
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2005-02-07
Brief Title:
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis Bowens Disease Skin Cancer or Stage I or Stage II Mycosis Fungoides
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Clinical Trial Using Topical Silicon Phthalocyanine Pc 4 Photodynamic Therapy PDT for the Treatment of Pre-Malignant and Malignant Skin Conditions
Status:
COMPLETED
Status Verified Date:
2011-01
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:
RATIONALE Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light When the drug is active tumor cells are killed Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer
PURPOSE This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis Bowens disease skin cancer or stage I or stage II mycosis fungoides
PURPOSE This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis Bowens disease skin cancer or stage I or stage II mycosis fungoides
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis Bowens disease squamous cell or basal cell skin cancer or stage IA IB IIA or IIB mycosis fungoides
Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants
Determine the antitumor mechanism of this therapy by monitoring tissue changes via clinical histological immunohistochemical and other biochemical markers in these participants
Determine preliminarily the dose of this therapy that results in highest clearing rates in these participants
OUTLINE This is a dose-escalation study
Participants receive topical silicon phthalocyanine 4 Pc 4 One hour later participants undergo photodynamic therapy Treatment repeats weekly for up to 3 weeks up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present
Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity Three additional participants are treated at the MTD
After completion of study therapy participants are followed for up to 2 weeks
PROJECTED ACCRUAL A total of 16-45 participants will be accrued for this study
Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis Bowens disease squamous cell or basal cell skin cancer or stage IA IB IIA or IIB mycosis fungoides
Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants
Determine the antitumor mechanism of this therapy by monitoring tissue changes via clinical histological immunohistochemical and other biochemical markers in these participants
Determine preliminarily the dose of this therapy that results in highest clearing rates in these participants
OUTLINE This is a dose-escalation study
Participants receive topical silicon phthalocyanine 4 Pc 4 One hour later participants undergo photodynamic therapy Treatment repeats weekly for up to 3 weeks up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present
Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity Three additional participants are treated at the MTD
After completion of study therapy participants are followed for up to 2 weeks
PROJECTED ACCRUAL A total of 16-45 participants will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-1Y04 | None | None | None |
| 10-03-01 | OTHER | None | None |
| CASE1Y04 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |