Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017485
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2001-06-06
Brief Title:
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study Of Photodynamic Therapy PDT For The Treatment Of Basal Cell Carcinoma BCC A DrugLight Dose Finding Study Utilizing 2-1-HEXYLOXYETHYL-2-DEVINYL PYROPHEOPHORBIDE-A HPPH-PHOTOCLOR
Status:
COMPLETED
Status Verified Date:
2011-03
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 light and drugs that make cancer cells more sensitive to light to kill tumor cells Photosensitizing drugs such as HPPH are absorbed by cancer cells and when exposed to light become active and kill the cancer cells
PURPOSE Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer
PURPOSE Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer
Detailed Description:
OBJECTIVES
Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer
Determine the drug dose light dose and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen
Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen
Determine the plasma clearance rates for HPPH in these patients
Determine the best combination of treatment parameters for a phase II study
OUTLINE This is a dose-escalation study
Patients receive HPPH IV on day 1 Patients undergo phototherapy on days 2-3
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose MED The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity
Patients are followed daily for 4 days at week 1 and at months 1 3 6 12 and 24
PROJECTED ACCRUAL A total of 4-25 patients will be accrued for this study
Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer
Determine the drug dose light dose and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen
Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen
Determine the plasma clearance rates for HPPH in these patients
Determine the best combination of treatment parameters for a phase II study
OUTLINE This is a dose-escalation study
Patients receive HPPH IV on day 1 Patients undergo phototherapy on days 2-3
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose MED The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity
Patients are followed daily for 4 days at week 1 and at months 1 3 6 12 and 24
PROJECTED ACCRUAL A total of 4-25 patients 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 |
|---|---|---|---|
| NCI-G01-1953 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |
| RPCI-DS-95-34 | None | None | None |