Fenretinide in Treating Patients With Cervical Neoplasia
NCT00003075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2018-10-24
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.
Conditions
- Cervical Cancer
- Precancerous Condition
Interventions
- DRUG
-
Fenretinide
Oral Fenretinide daily for 6 months with 3 days of rest every month.
- OTHER
-
Placebo
Oral placebo daily for 6 months with 3 days of rest every month.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Michele Follen, MD, PhD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1993-03-05
- Primary Completion
- 2001-05-01
- Completion
- 2001-05-01
Countries
- United States
Study Locations
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