A Phase 1 interventional study of motexafin lutetium and photodynamic therapy in Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 2 and Cervical Intraepithelial Neoplasia Grade 3, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Prevention
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
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.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 7,250 interventional studies indexed under Neoplasms.
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Inclusion Criteria:
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.
Drug: motexafin lutetium · Procedure: loop electrosurgical excision procedure · Other: laboratory biomarker analysis
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.
Drug: motexafin lutetium · Drug: photodynamic therapy · Procedure: loop electrosurgical excision procedure · Other: laboratory biomarker analysis
Given IV
Also known as: Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex, PCI-0123
Undergo laser therapy
Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic
Undergo LEEP
Also known as: LEEP, Loop Electrosurgical Excision
Correlative studies
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
Time frame: Up to 24 hours
Maximal differential in Lutrin tissue levels between normal and dysplastic cells (Part 1)
Time frame: At the time of LEEP
Percentage of tissue demonstrating PDT related effects (apoptosis/ necrosis) for normal versus abnormal epithelium at each total fluence for each LEEP cone biopsy specimen
A simplified graphical analysis will be utilized to determine the fluence that provides the maximal differential area between neoplastic and normal cervical epithelium and stroma.
Time frame: At LEEP time
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)