Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma

NCT00847522 | Completed Phase 1 Results DMC

• 1 other identifier: HCI26818
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it. This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.

Conditions

Cancer

Keywords

melanoma; skin cancer; lymph node; sentinel lymph node; malignant melanoma; mapping

Outcome Measures

Primary Outcomes (1)

• Percentage of Agreement Between the Detection of SLNs

  There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.

  2 days

Secondary Outcomes (1)

• Safety Evaluation of Intradermal Fluorescein Injections.

  1 month

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: Fluorescein

Interventions

Fluorescein DRUG

Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.

Also known as: Fluorescite®

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
• Between 18 and 90 years of age.
• Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues)
• Have a primary melanoma meeting one of the following criteria:
• Primary melanoma was ≥ 0.75 mm Breslow thickness and Clark level III or
• Primary melanoma was Clark level IV/V or
• Primary melanoma was ulcerated or
• Primary tumor mitotic \>1/mm2 or
• Primary melanoma was less than 0.75 mm Breslow thickness with one or more poor prognostic features (regression \> 75%, vertical growth phase, mitotic Count \> 1/mm2, transected deep biopsy margin) or
• Have had a prior excision (non-wide local excision) of a melanocytic lesion with development of a primary melanoma in the excision scar or
• Have had a wide locale excision within the past 120 days of a primary melanoma as defined in (a-f) above but not yet undergone a SLNB
• Clinically negative lymph nodes.
• ECOG performance status 0-1

You may not qualify if:

• Primary melanoma of the eye, mucous membranes or internal viscera.
• Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional or distant metastatic disease.
• Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to the lymph node basin.
• Allergy to radiocolloid or fluorescein.
• Inability to localize 1-2 SLN drainage basins via lymphatic mapping. (e.g., no basin found which emits gamma-radiation after injection with technecium-99m or more than 2 basins are found which emit gamma-radiation.)
• Prior completion lymph node dissection or SLNB that may have altered the lymphatic drainage from the primary cutaneous melanoma to a potential lymph node basin.
• Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol, or be exacerbated by therapy.
• Melanoma-related operative procedures not corresponding to criteria described in the protocol.
• Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
• History of organ transplantation.
• Pregnant or lactating women.
• Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
• Nonmalignant systemic disease (e.g., cardiovascular, renal, hepatic, etc.) that precludes a patient from being subjected to any of the treatment options or that would prevent prolonged follow-up based on the physician's judgment.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Skin Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Mark Wade
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

8012135746

Study Officials

• Robert H Andtbacka, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 patients were enrolled in the Phase 1 portion of the trial. 80 patients were enrolled in the Phase 2 portion of the trial. 90 patients were enrolled total for the Phase 1 and 2 portions. Results are reported for the 80 patients on the Phase 2 portion.

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Locations

US (1)