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| ID | Type | Description | Link |
|---|---|---|---|
| SWOG-9507 | Other Identifier | SWOG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source |
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Closed due to poor accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Fenretinide 200 mg PO days 1-25, q 28 days x 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenretinide | Drug | 200 mg/day PO, days 1-25 q 28 days x 6 cycles. |
|
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
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| Name | Affiliation | Role |
|---|---|---|
| Omer Kucuk, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States | ||
| Arizona Cancer Center |
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| 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 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017313 | Fenretinide |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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