|
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia Clinical research trials and Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia. Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia clinical trial. Subjects frequently get the best healthcare possible for their Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia  Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
For Condition: Cervical Cancer
Status: Recruiting
Sponsor(s): University of Pittsburgh Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnComerci, Study Chair, University of Pittsburgh Cancer Institute
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting John Comerci 412-641-5418
Additional Information:
Study ID Numbers: CDR0000067801; PCI-07931,NCI-T98-0066
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005808
Other Cervical Cancer Studies:
1. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
2. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
3. Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia
4. Fenretinide in Treating Patients With Cervical Neoplasia
5. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Related Studies:
Other Cervical Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
|
|
|
|
|
|
|
|
