Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00386906

Purpose

The goal of this clinical research study is to localize the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.

Primary Objectives:

Identify the rate of sentinel lymph node (SLN) positivity in conjunctival/eyelid melanomas
Determine the false negative rate for SLN biopsy for the same

Secondary Objective:

Determine the complication rate for this technique, particularly with respect to local ocular and periocular side effects as well as the risk of facial nerve damage

Condition	Intervention	Phase
Eye Disease Melanoma	Procedure: Sentinel Lymph Node Mapping and Biopsy	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Sentinel Lymph Node Localization and Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Eye Diseases Melanoma

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with SLN Positivity in Conjunctival/eyelid Melanomas [ Time Frame: Ophthalmologic exam to check for recurrence every three months during Year 1 and every 6 months during Years 2-5. ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	May 2000
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SLN Biopsy SLN = Sentinel Lymph Node	Procedure: Sentinel Lymph Node Mapping and Biopsy Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Detailed Description:

Patients in this study have had their conjunctival or eyelid tumor surgically removed or is scheduled to have it removed. Patients will have lymphatic mapping before their tumor is removed. Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken.

Patients will then go to the operating room and undergo intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, patients will go on to have complete lymph node dissection, which involves removal of all the lymph nodes around the positive SLN. Then the disease will be restaged and patients may require further treatment after consultation with their oncologist.

Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/eyelid melanoma.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at M.D. Anderson Cancer Center.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants must be 18 years of age or older.
Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness
Ability to undergo surgery under general anesthesia
A chest X-ray (CXR), liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis
Participants must have a negative ultrasound of regional lymph nodes.
Capable of giving written informed consent
Women of childbearing potential are not eligible unless tested negative for pregnancy prior to SLN mapping and biopsy.

Exclusion Criteria: N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386906

Contacts

Contact: Bita Esmaeli, MD

713-792-6920

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Bita Esmaeli, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Bita Esmaeli, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Bita Esmaeli, MD/Assoc. Professor )
Study ID Numbers:	GSP00-106
Study First Received:	October 10, 2006
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00386906 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Melanoma
Conjunctival Melanoma
Malignant Melanoma of the Conjunctiva
Malignant Melanoma of the Eyelid
Sebaceous Cell Carcinoma
Sebaceous Cell Carcinoma of the Conjunctiva

Sebaceous Cell Carcinoma of the Eyelid
Sentinel Lymph Node
Lymphatic Mapping
Eyelid
Eyelid Lesion

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Eye Diseases
Neoplasms, Nerve Tissue

Nevi and Melanomas
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Melanoma
Carcinoma

ClinicalTrials.gov processed this record on November 30, 2009