Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With 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

Objectives

1. 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).
2. 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.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

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

Other:

• 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

Patient Characteristics:

Age:

• 16 to 65

Performance status:

• 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Absolute neutrophil count greater than 2,000/mm³
• Platelet count normal

Hepatic:

• Liver enzymes normal
• No liver impairment

Renal:

• BUN normal
• Creatinine normal
• No renal insufficiency

Cardiovascular:

• No coronary artery disease
• No cardiac arrhythmia
• No congestive heart failure

Other:

• 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

Expected Enrollment

A maximum of 54 patients will be accrued for this study.

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.

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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