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| Descriptive Information Fields | |||||
| Brief Title † | Fenretinide in Treating Patients With Cervical Neoplasia | ||||
| Official Title † | A Randomized Double-Blind Study of N-(4-Hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3 | ||||
| Brief Summary | RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia. |
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| Detailed Description | OBJECTIVES: I. Determine the efficacy of femretinide (N-(4-hydroxyphenyl) retinamide; 4-HPR) at regressing cervical intraepithelial neoplasia (CIN). II. Document the qualitative and quantitative toxicity of 4-HPR in women with CIN. OUTLINE: This is a double blinded study. Patients are randomized to receive either fenretinide or placebo. Patients are administered fenretinide or a placebo PO daily for 6 months with 3 days of rest every month. Patients undergo colposcopy, colpophotography, and Pap smears at 3, 6, 9, and 12 months. Patients undergo cervical biopsy at 6 and 12 months to assess changes. PROJECTED ACCRUAL: 84-100 patients will be accrued. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cervical Cancer Precancerous/Nonmalignant Condition |
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| Intervention † | Drug: fenretinide | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | September 1992 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective contraception Fasting triglyceride less than 2 times normal No prior malignancy Must consent to colposcopy and cervical biopsy PRIOR CONCURRENT THERAPY: Not specified |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003075 | ||||
| Organization ID | CDR0000065761 | ||||
| Secondary IDs †† | MDA-ID-92027, NCI-P97-0092 | ||||
| Study Sponsor † | M.D. Anderson Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | September 4, 2008 | ||||
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