Study Stopped
Closed due to poor accrual.
SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth
A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
3 other identifiers
interventional
5
1 country
15
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth. PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Dec 1997
Shorter than P25 for phase_2 head-and-neck-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Posted
Study publicly available on registry
September 10, 2004
CompletedJuly 24, 2012
July 1, 2012
2.2 years
November 1, 1999
July 20, 2012
Conditions
Keywords
Study Arms (1)
treatment
EXPERIMENTALFenretinide 200 mg PO days 1-25, q 28 days x 6 cycles.
Interventions
200 mg/day PO, days 1-25 q 28 days x 6 cycles.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (15)
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Omer Kucuk, MD
Barbara Ann Karmanos Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
September 10, 2004
Study Start
December 1, 1997
Primary Completion
March 1, 2000
Study Completion
March 1, 2000
Last Updated
July 24, 2012
Record last verified: 2012-07