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Topical Sirolimus in Patients With Basal Cell Nevus Syndrome and in Healthy Participants

NCT00433485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-09-23

No results posted yet for this study

Summary

RATIONALE: Studying samples of blood and tissue from patients with basal cell nevus syndrome and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to basal cell nevus syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sirolimus may keep basal cell skin cancer from forming in patients with basal cell nevus syndrome.

PURPOSE: This phase I trial is studying topical sirolimus in patients with basal cell nevus syndrome and in healthy participants.

Conditions

  • Neoplastic Syndrome
  • Non-melanomatous Skin Cancer

Interventions

DRUG

sirolimus

GENETIC

comparative genomic hybridization

GENETIC

gene expression analysis

GENETIC

microarray analysis

GENETIC

protein expression analysis

GENETIC

proteomic profiling

OTHER

laboratory biomarker analysis

OTHER

mass spectrometry

PROCEDURE

biopsy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Allen E. Bale, MD · Yale University

Study Design

Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Primary Completion
2008-03-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00433485 on ClinicalTrials.gov