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A Phase II Double-Blind Study of Topical Tretinoin With or Without Oral 4-HPR (Fenretinide) in Patients With the Dysplastic Nevus Syndrome

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Double-Blind Study of Topical Tretinoin With or Without Oral 4-HPR (Fenretinide) in Patients With the Dysplastic Nevus Syndrome

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Lynn Mara Schuchter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • melanoma
  • Dysplastic Nevus Syndrome
  • Melanoma



University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104