Working... Menu

SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003223
Recruitment Status : Terminated (Closed due to poor accrual.)
First Posted : September 10, 2004
Last Update Posted : July 24, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: fenretinide Phase 2

Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia. II. Assess the toxicity of fenretinide in these patients.

OUTLINE: Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses. After 6 courses, patients receive a post-treatment biopsy. Patients exhibiting disease progression or unacceptable toxicities are removed from the study. Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 51 patients will be accrued.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
Study Start Date : December 1997
Actual Primary Completion Date : March 2000
Actual Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: treatment
Fenretinide 200 mg PO days 1-25, q 28 days x 6 cycles.
Drug: fenretinide
200 mg/day PO, days 1-25 q 28 days x 6 cycles.
Other Name: N-(4-hydroxyphenyl)retinamide, 4-HPR

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven oral mucosal intraepithelial neoplasia Stage II: moderate dysplasia, keratosis with atypia Stage III: severe keratinizing or nonkeratinizing dysplasia No myelodysplastic syndrome No retinopathies

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: Prior surgical ablation of prior dysplastic sites allowed Other: At least 2 months since prior therapy toxicities Patient Characteristics-- Age: Not specified Performance Status: SWOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study

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 identifier (NCT number): NCT00003223

Layout table for location information
United States, Arizona
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute

Layout table for additonal information
Responsible Party: Southwest Oncology Group Identifier: NCT00003223     History of Changes
Other Study ID Numbers: CDR0000066085
SWOG-9507 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2004    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Southwest Oncology Group:
lip and oral cavity cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs