Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Prevention Active 18 and over Other 2003-0811 NCT00346502

Trial Description

Summary

The incidence of melanoma has risen steadily over the last several decades. One type of benign pigmented lesion generally agreed to be a precursor of cutaneous melanoma is the dysplastic melanocytic nevus (DMN). Furthermore, DMN are frequently multiple and are encountered on both the trunk and extremities. It is therefore logical to propose that if a nontoxic topical preparation can be found which induces cell death within these abnormal melanocytes, a large number of these presumed precancerous lesions could be adequately treated without multiple excisions. Additionally, in the future this topical preparation could be used as a chemopreventive agent to prevent a dysplastic nevus or similar precancerous melanocytic lesion from progressing into melanoma.

We hypothesize that 20% betulinic acid ointment applied locally to dysplastic nevi with moderate to severe dysplasia will induce regression via apoptotic pathways.

Further Study Information

In 1998, the risk of malignant melanoma for all Americans was approaching 1 in 100, which is a 1,500% increase over the last half century. Estimates, based on this trend, postulate that today's risk for Americans acquiring melanoma is close to 1 in 68.

Several risk factors have been defined for the development of melanoma. The most common and avoidable risk factor is exposure to radiation from the sun. Ultraviolet B radiation (290-320 nm) appears to play a significant role in melanoma development. The frequency, intensity, and timing of the exposure greatly influence the risk. The risk of developing malignant melanoma appears to be related to intermittent exposures as opposed to chronic exposures. In fact, three or more blistering sunburns before the age of 20 significantly increased the risk of malignant melanoma. Melanoma accounts for only 5% of all skin cancers, but results in 75% of all deaths attributed to skin cancer. Surgical treatment of localized cutaneous melanoma results in a high cure rate. Cutaneous melanoma that is metastatic beyond the confines of regional lymph nodes still remains, in most instances, an incurable disease.

Eligibility Criteria

Inclusion Criteria:

• Histologically documented dysplastic nevi (at least 2) with moderate to severe dysplasia

• ECOG Performance Status < or = 2

Exclusion Criteria:

• Pregnant or nursing females

• Immuno-suppressed patients

• Patients with other active malignancies within past 5 years

• Patients with EXTENSIVE chronic skin diseases (psoriasis, atopic dermatitis, or xeroderma pigmentosa).

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Illinois Cancer Center

Tapas K. Das Gupta, MD, PhD, DSc

Principal Investigator

Cathleen M Schaeffer, RN, BSN, OCN		Ph: 312-413-3863
		Email: cschaffe@uic.edu

Tanya Eitzenhoefer, B.S. CPA		Ph: 312-996-5658
		Email: tanya@uic.edu

U.S.A.
Illinois
	Chicago
	University of Illinois Cancer Center
		Cathleen M Schaeffer, RN, BSN, OCN	Ph: 312-413-3863
			Email: cschaffe@uic.edu
		Tapas K Das Gupta, MD, PhD, DSc	Principal Investigator
		Michael A Warso, M.D.	Sub-Investigator
		George I Salti, M.D.	Sub-Investigator
		Karen L Maloney, M.D.	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00346502
Information obtained from ClinicalTrials.gov on May 27, 2008