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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Motexafin lutetium

Criteria

Inclusion Criteria:

• Cervical intraepithelial neoplasia (CIN) grade II or III

• No cytologic, colposcopic, or histologic evidence of invasive squamous cell carcinoma

• No evidence of glandular atypia on Pap smear, endocervical curettage, or biopsy

• No inadequate colposcopy (i.e., entire transformation zone cannot be visualized and/or upper limit of a colposcopically abnormal lesion cannot be visualized fully)

• HIV positive but not currently on antiviral therapy

• Performance status - 0-2

• WBC greater than 4,000/mm^3

• Absolute neutrophil count greater than 2,000/mm^3

• Platelet count normal

• Liver enzymes normal

• No liver impairment

• BUN normal

• Creatinine normal

• No renal insufficiency

• No coronary artery disease

• No cardiac arrhythmia

• No congestive heart failure

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for at least 1 month after study

• No other serious medical illness (e.g., non-insulin and insulin-dependent diabetes or connective tissue disorders)

• No other prior or concurrent malignancy

• No known G6PD deficiency

• No porphyria

• No history of 2 prior ablative/excisional therapies (i.e., cryotherapy, laser ablation, loop electrical excision procedure, or cold knife cone biopsy)

• No concurrent non-steroidal anti-inflammatory drugs (NSAIDS)

• No other concurrent significant medication/therapy such as:

• Anti-hypertensives, anti-arrhythmics, or inotropic agents for cardiopulmonary disease

• Diuretics for renal insufficiency

• Steroids or NSAIDs for connective tissue disorders