NCT00005808

Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia

Phase I Study Photodynamic Therapy Using Lutrin (Lutetium Texaphyrin) in the Treatment of Patients With Cervical Intraepithelial Neoplasia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasia Grade 2
• Cervical Intraepithelial Neoplasia Grade 3

Interventions

Type	Name	Description
DRUG	motexafin lutetium	Given IV
DRUG	photodynamic therapy	Undergo laser therapy
PROCEDURE	loop electrosurgical excision procedure	Undergo LEEP
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-12-01
• Primary completion: 2004-04-01
• First posted: 2003-01-27
• Last updated: 2013-02-07

Locations

1 site across 1 country: United States