Clinical trial · Interventional
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
Phase I Study Photodynamic Therapy Using Lutrin (Lutetium Texaphyrin) in the Treatment of Patients With Cervical Intraepithelial Neoplasia
NCT00005808CI-TRIAL-00009337terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia Grade 2 | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade 3 | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| loop electrosurgical excision procedure | Procedure | — | UNRESOLVED |
| motexafin lutetium | Drug | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 (lutetium texaphyrin, LEEP)
- description
- 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.
- interventionNames
- Drug: motexafin lutetium
- Procedure: loop electrosurgical excision procedure
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Part 2 (lutetium texaphyrin, laser therapy, LEEP)
- description
- 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.
- interventionNames
- Drug: motexafin lutetium
- Drug: photodynamic therapy
- Procedure: loop electrosurgical excision procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.