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NCT00003223 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00003223
Other study ID # CDR0000066085
Secondary ID SWOG-9507U10CA03
Status Terminated
Phase Phase 2
First received November 1, 1999
Last updated July 20, 2012
Start date December 1997
Est. completion date March 2000

Study information
Verified date July 2012
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date March 2000
Est. primary completion date March 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• fenretinide
200 mg/day PO, days 1-25 q 28 days x 6 cycles.

Locations
Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Veterans Affairs Medical Center - Detroit Detroit Michigan
United States University of Kansas Medical Center Kansas City Kansas
United States Veterans Affairs Medical Center - Kansas City Kansas City Missouri
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Veterans Affairs Medical Center - Lexington Lexington Kentucky
United States MBCCOP - LSU Medical Center New Orleans Louisiana
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas
United States Arizona Cancer Center Tucson Arizona
United States Veterans Affairs Medical Center - Tucson Tucson Arizona

Sponsors (2)
Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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