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Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00386906
First received: October 10, 2006
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to find 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.


Condition Intervention Phase
Eye Disease
Melanoma
Procedure: Sentinel Lymph Node Mapping and Biopsy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients with Sentinel Lymph Node (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 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sentinel Lymph Node (SLN) Biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
Procedure: Sentinel Lymph Node Mapping and Biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Detailed Description:

You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed. You will have lymphatic mapping before the 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.

If you are able to become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test, within 7 days before the biopsy. To take part in this study, you must not be pregnant.

You will then go to the operating room and have intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, you 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 you may require further treatment after consultation with their oncologist.

Your medical record will be reviewed, and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease. The information collected from your medical records will include information about your sex, age, what type of cancer that you have, as well as the size of the cancer and its location.

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.

Length of Study:

Your active participation on this study will be over once the biopsy is over. You will continue to be observed on study for 5 years after the biopsy.

Long-Term Follow-Up:

Every 3 months for the first year after the biopsy, and every 6 months after that until 5 years after the biopsy, you will have an eye exam to check the status of the disease.

Every 6 months for the first year after the biopsy, blood (less than 1 teaspoon) will be drawn for liver function tests. You will also have a chest x-ray. You will then have these tests 1 time each year for 5 years after the biopsy.

You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back. The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy.

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

  Eligibility

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

Inclusion Criteria:

  1. Participants must be 18 years of age or older.
  2. Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV.
  3. A CXR, liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis.
  4. Participant must have a negative ultrasound of regional lymph nodes (i.e., within 6 weeks of study enrollment).
  5. Patient provided written informed consent. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC Policy for Consenting Non-English Speaking Participants.

Exclusion Criteria:

1) Pregnant or nursing females.

  Contacts and Locations
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, see Learn About Clinical Studies.

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

Contacts
Contact: Bita Esmaeli, MD 713-794-1247

Locations
United States, Texas
UT MD 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00386906     History of Changes
Other Study ID Numbers: GSP00-106, NCI-2012-01480
Study First Received: October 10, 2006
Last Updated: July 15, 2014
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:
Eye Diseases
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014