Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	18 and over	NCI	E-2695 UPCC-2600, NCI-P98-0134, NCT00003601

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.

Entry 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

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

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

Expected Enrollment

There will be 38 patients accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Lynn Mara Schuchter, MD, Protocol chair		Ph: 215-662-7907 Email: Lynn.Schuchter@uphs.upenn.edu

Registry Information
Official Title		A Phase II Double-Blind Study of Topical Tretinoin with or without Oral 4-HPR (Fenretinide) in Patients with the Dysplastic Nevus Syndrome
Trial Start Date		1998-09-24
Trial Completion Date		2000-03-16
Registered in ClinicalTrials.gov		NCT00003601
Date Submitted to PDQ		1998-09-25
Information Last Verified		2008-03-21

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