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

NCT00005808 | Terminated Phase 1

• 4 other identifiers: NCI-2012-02328MWH-99-077U01CA099168CDR0000067801
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 2; Cervical Intraepithelial Neoplasia Grade 3

Outcome Measures

Primary Outcomes (3)

• 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

  Up to 24 hours

• Maximal differential in Lutrin tissue levels between normal and dysplastic cells (Part 1)

  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.

  At LEEP time

Study Arms (2)

Part 1 (lutetium texaphyrin, LEEP)

EXPERIMENTAL

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

Part 2 (lutetium texaphyrin, laser therapy, LEEP)

EXPERIMENTAL

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

Interventions

motexafin lutetium DRUG

Given IV

Also known as: Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex, PCI-0123

Part 1 (lutetium texaphyrin, LEEP); Part 2 (lutetium texaphyrin, laser therapy, LEEP)

photodynamic therapy DRUG

Undergo laser therapy

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Part 2 (lutetium texaphyrin, laser therapy, LEEP)

loop electrosurgical excision procedure PROCEDURE

Undergo LEEP

Also known as: LEEP, Loop Electrosurgical Excision

Part 1 (lutetium texaphyrin, LEEP); Part 2 (lutetium texaphyrin, laser therapy, LEEP)

laboratory biomarker analysis OTHER

Correlative studies

Part 1 (lutetium texaphyrin, LEEP); Part 2 (lutetium texaphyrin, laser therapy, LEEP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

motexafin lutetium; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• John Comerci

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Primary Completion: April 1, 2004
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)