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Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Eye Disease, Melanoma

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Trial Information

Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas

Outcome Time Frame:

Ophthalmologic exam to check for recurrence every three months during Year 1 and every 6 months during Years 2-5.

Safety Issue:

No

Principal Investigator

Bita Esmaeli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

GSP00-106

NCT ID:

NCT00386906

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Eye Disease
  • Melanoma
  • 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
  • Eye Diseases
  • Melanoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030