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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Grade II or III Cervical Intraepithelial Neoplasia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Prevention	Completed	18 to 65	NCI	PCI-07931 NCI-T98-0066, NCT00005808, T98-0066, PCI-01-081

Trial Description

Purpose:

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.

Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in treating patients who have cervical intraepithelial neoplasia.

Eligibility:

• 16-65 years old
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of lutetium texaphyrin followed by laser light to the cervix. Patients will then undergo a procedure in which a heated wire is used to remove the abnormal tissue from the cervix. Patients will receive follow-up evaluations at 48 hours, once a week for 1 month, and at 4 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Center at Magee-Womens Hospital

John Comerci, MD, Protocol chair		Ph: 412-641-5418 Email: jcomerci@mail.magee.edu

Registry Information
Official Title		Phase I Study of Photodynamic Therapy Using LUTRIN (Lutetium Texaphyrin) in the Treatment of Patients with Cervical Intraepithelial Neoplasia
Trial Start Date		2000-10-15
Registered in ClinicalTrials.gov		NCT00005808
Date Submitted to PDQ		2000-03-17
Information Last Verified		2004-12-29
NCI Grant/Contract Number		P30-CA47904

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