Phase I Study Photodynamic Therapy Using Lutrin (Lutetium Texaphyrin) in the Treatment of Patients With Cervical Intraepithelial Neoplasia
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Optimal dosage with the least toxicity of lutetium texaphyrin (Part 1)
A simplified graphical analysis will be utilized to determine the drug dose and time after administration that provides the largest differential area between lutein texaphyrin tissue levels in neoplastic and normal cervical tissue
Up to 24 hours
University of Pittsburgh
United States: Food and Drug Administration
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