Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005808
Status:
TERMINATED
Last Update Posted:
2013-02-07
First Post:
2000-06-02
Brief Title:
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Photodynamic Therapy Using Lutrin Lutetium Texaphyrin in the Treatment of Patients With Cervical Intraepithelial Neoplasia
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in treating patients who have cervical intraepithelial neoplasia Photodynamic therapy uses light and drugs such as lutetium texaphyrin that make abnormal cells more sensitive to light and may kill abnormal cells in the cervix and prevent the development of cervical cancer
Detailed Description:
OBJECTIVES
I Determine the optimal dosage with the least toxicity of lutetium texaphyrin as well as the length of time following its systemic injection that provides the maximum differential in drug uptake between the target dysplastic squamous cells and normal squamous epithelium when given to patients with cervical intraepithelial neoplasia CIN
II Determine by histomorphometry the photodynamic light dose that demonstrates the greatest treatment selectivity between normal cervical epithelium and CIN with the least amount of cervical pain and necrosis
OUTLINE This is a dose-escalation study of lutetium texaphyrin part 1 followed by a dose-escalation study of light fluence part 2
Part 1 Patients receive lutetium texaphyrin IV over 5-20 minutes Patients undergo in vivo tissue assessment by spectrometer at 0 1 3 5 12 and 24 hours and loop electrical excision procedure LEEP at 24 hours after lutetium texaphyrin infusion
Part 2 Patients receive lutetium texaphyrin IV over 5-20 minutes A laser delivers 730 nm of light to the cervix for 4 8 or 16 minutes Patients undergo LEEP at 4 8 or 12 hours after exposure of the cervix to the light source
Cohorts of 9 patients receive escalating doses of lutetium texaphyrin part 1 and then light fluence part 2 until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity
Patients are followed at 48 hours weekly for 1 month and then at 4 months
PROJECTED ACCRUAL A maximum of 54 patients will be accrued for this study
I Determine the optimal dosage with the least toxicity of lutetium texaphyrin as well as the length of time following its systemic injection that provides the maximum differential in drug uptake between the target dysplastic squamous cells and normal squamous epithelium when given to patients with cervical intraepithelial neoplasia CIN
II Determine by histomorphometry the photodynamic light dose that demonstrates the greatest treatment selectivity between normal cervical epithelium and CIN with the least amount of cervical pain and necrosis
OUTLINE This is a dose-escalation study of lutetium texaphyrin part 1 followed by a dose-escalation study of light fluence part 2
Part 1 Patients receive lutetium texaphyrin IV over 5-20 minutes Patients undergo in vivo tissue assessment by spectrometer at 0 1 3 5 12 and 24 hours and loop electrical excision procedure LEEP at 24 hours after lutetium texaphyrin infusion
Part 2 Patients receive lutetium texaphyrin IV over 5-20 minutes A laser delivers 730 nm of light to the cervix for 4 8 or 16 minutes Patients undergo LEEP at 4 8 or 12 hours after exposure of the cervix to the light source
Cohorts of 9 patients receive escalating doses of lutetium texaphyrin part 1 and then light fluence part 2 until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity
Patients are followed at 48 hours weekly for 1 month and then at 4 months
PROJECTED ACCRUAL A maximum of 54 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 |
|---|---|---|---|
| CDR0000067801 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA099168 |
| MWH-99-077 | None | None | None |
| U01CA099168 | NIH | None | None |