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Fenretinide in Treating Patients With Cervical Neoplasia

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ClinicalTrials.gov Identifier: NCT00003075
Recruitment Status : Completed
First Posted : May 27, 2004
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Precancerous Condition Drug: Fenretinide Other: Placebo Phase 3

Detailed Description:

OBJECTIVES: I. Determine the efficacy of fenretinide (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 by mouth (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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : March 5, 1993
Actual Primary Completion Date : May 1, 2001
Actual Study Completion Date : May 1, 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fenretinide Drug: Fenretinide
Oral Fenretinide daily for 6 months with 3 days of rest every month.
Other Name: 4-HPR

Placebo Comparator: Placebo Other: Placebo
Oral placebo daily for 6 months with 3 days of rest every month.




Primary Outcome Measures :
  1. Efficacy of Fenretinide at Regressing CIN [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003075


Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Michele Follen, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003075     History of Changes
Other Study ID Numbers: ID92-027
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-92027 ( Other Identifier: UT MD Anderson Cancer Center )
NCI-P97-0092
CDR0000065761 ( Registry Identifier: NCI PDQ )
First Posted: May 27, 2004    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Keywords provided by M.D. Anderson Cancer Center:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fenretinide
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs