Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome

NCT ID: NCT00003601

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-23
• Study Completion Date: 2004-03-02

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tretinoin and/or fenretinide may be an effective way to prevent the recurrence or further development of dysplastic nevus syndrome.

PURPOSE: Randomized phase II trial to compare the effectiveness of tretinoin with or without fenretinide in treating patients with dysplastic nevus syndrome.

Detailed Description

OBJECTIVES: I. Compare the efficacy (clinical and histologic evidence of regression) of topical tretinoin with or without systemic fenretinide in patients with dysplastic nevi with personal or family history of cutaneous melanoma.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to personal history of cutaneous melanoma vs family history of cutaneous melanoma in at least 2 blood relatives. Patients are randomized to one of two treatment arms. Arm I: Patients receive topical tretinoin twice daily and oral fenretinide once a day for 6 months. Tretinoin is applied to one half of the back with the untreated side of the back serving as a matched control. Arm II: Patients receive topical tretinoin as in arm I twice daily and oral placebo once a day for 6 months. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Patients are followed at 6 months.

PROJECTED ACCRUAL: There will be 38 patients accrued for this study.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

fenretinide

Intervention Type: DRUG

tretinoin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Clinically dysplastic nevi with a personal history of cutaneous melanoma and/or a family history of cutaneous melanoma in two or more blood relatives (blood relatives include first, second, or third degree relatives from the same blood line) Clinically dysplastic nevi defined as: At least 4 mm in diameter and flatness (either a component or throughout) with at least 1 of the following: Variable pigmentation Irregular or asymmetrical outline Indistinct border Must have at least 10 or more large (diameter at least 4 mm) clinically dysplastic nevi on the trunk or extremities (excluding head, pubic area, breasts in women, hands, and/or below the knees) No stage III or IV melanoma Patients with history of melanoma who received adjuvant therapy must be more than 1 year from completion of therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL AST less than 2 times normal Alkaline phosphatase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No symptomatic arteriosclerotic coronary artery disease No history of coronary artery disease Other: Fasting triglyceride level less than 210 mg/dL Fasting cholesterol level less than 350 mg/dL No nonmalignant disease that would preclude administration of retinoids No psychiatric conditions that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior coronary bypass surgery Other: No prior systemic retinoids No concurrent vitamin (except a daily multivitamin) or dietary supplement No concurrent systemic therapy for hyperlipidemia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Lynn Mara Schuchter, MD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

E-2695

Identifier Type: -

Identifier Source: secondary_id

UPCC-2600

Identifier Type: -

Identifier Source: secondary_id

NCI-P98-0134

Identifier Type: -

Identifier Source: secondary_id

CDR0000066674

Identifier Type: -

Identifier Source: org_study_id