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Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia Clinical research trials and Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia. Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia  Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
For Condition: recurrent cervical cancer,stage 0 cervical cancer,prevention of cervical cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.
Details: OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. II. Compare the qualitative and quantitative toxicities of these treatment regimens in these patients. III. Establish the biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients. PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months. PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed or recurrent cervical intraepithelial neoplasia grade 2-3; Involves area 3 times larger than the biopsy site (4-6 mm2 lesion) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 12 months - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Fertile patients must use effective contraception; No prior malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MicheleFollen, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: CDR0000067921; NCI-P00-0149,MDA-ID-92026
Study Start Date: June 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006079
Other Prevention Of Cervical Cancer Studies:
1. Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
2. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
3. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
4. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
5. Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Related Studies:
Other prevention of cervical cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
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