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Sponsors and Collaborators: |
University of Pittsburgh National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005808 |
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in treating patients who have cervical intraepithelial neoplasia.
Condition | Intervention | Phase |
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Cervical Cancer Precancerous/Nonmalignant Condition |
Drug: motexafin lutetium |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention |
Official Title: | Phase I Study of Photodynamic Therapy Using LUTRIN (Lutetium Texaphyrin) in the Treatment of Patients With Cervical Intraepithelial Neoplasia |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of lutetium texaphyrin (part 1) followed by a dose-escalation study of light fluence (part 2).
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
UPMC Cancer Center at Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213-3180 |
Study Chair: | John T. Comerci, MD | University of Pittsburgh |
Study ID Numbers: | CDR0000067801, PCI-07931, NCI-T98-0066, PCI-01-081 |
Study First Received: | June 2, 2000 |
Last Updated: | September 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00005808 History of Changes |
Health Authority: | United States: Federal Government |
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
Photosensitizing Agents Radiation-Sensitizing Agents Precancerous Conditions Carcinoma in Situ |
Motexafin lutetium Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms by Histologic Type Precancerous Conditions Physiological Effects of Drugs Pharmacologic Actions Cervical Intraepithelial Neoplasia Carcinoma Neoplasms |
Photosensitizing Agents Radiation-Sensitizing Agents Therapeutic Uses Carcinoma in Situ Motexafin lutetium Dermatologic Agents Neoplasms, Glandular and Epithelial |