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A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3


Phase 3
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Efficacy of Fenretinide at Regressing CIN

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID92-027

NCT ID:

NCT00003075

Start Date:

September 1992

Completion Date:

May 2001

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009