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Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
This study has been completed.
First Received: June 2, 2000   Last Updated: September 6, 2008   History of Changes
Sponsors and Collaborators: University of Pittsburgh
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005808
  Purpose

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
Cervical Cancer
Precancerous/Nonmalignant Condition
Drug: motexafin lutetium
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Motexafin lutetium Motexafin Antrin
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
Detailed Description:

OBJECTIVES:

  • 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).
  • 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.

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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age:

  • 16 to 65

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005808

Locations
United States, Pennsylvania
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: John T. Comerci, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Study placed in the following topic categories:
Photosensitizing Agents
Radiation-Sensitizing Agents
Precancerous Conditions
Carcinoma in Situ
Motexafin lutetium
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009