Overview

This trial is active, not recruiting.

Conditions eye disease, melanoma
Treatment sentinel lymph node mapping and biopsy
Phase phase 1
Sponsor M.D. Anderson Cancer Center
Start date May 2000
End date May 2017
Trial size 38 participants
Trial identifier NCT00386906, GSP00-106, NCI-2012-01480

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
sentinel lymph node mapping and biopsy
Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Primary Outcomes

Measure
Number of Patients with Sentinel Lymph Node (SLN) Positivity in Conjunctival/eyelid Melanomas
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
Principal investigator Bita Esmaeli, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.