ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 12 for:    "Atypical mole syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003601
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : July 24, 2008
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: fenretinide Drug: tretinoin Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Primary Purpose: Prevention
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
Study Start Date : September 1998
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Tretinoin





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003601


Locations
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lynn Mara Schuchter, MD Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier: NCT00003601     History of Changes
Other Study ID Numbers: CDR0000066674
E-2695
UPCC-2600
NCI-P98-0134
First Posted: August 26, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: March 2008

Keywords provided by National Cancer Institute (NCI):
melanoma

Additional relevant MeSH terms:
Dysplastic Nevus Syndrome
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nevus
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents