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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00847522
First received: February 17, 2009
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: Fluorescein
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The primary goal of this study is to evaluate the ability of intradermal fluorescein to detect sentinel lymph nodes (SLNs) in patients with stage I and stage II melanoma. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the co-localization between fluorescein and technetium-99m labeled sulfur colloid in SLNs. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
  • To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
  • To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN ex-vivo gamma radiation intensity. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
  • To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
  • To evaluate if fluorescein fluorescence can be detected in the SLN after fixation and histological processing. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
  • To evaluate the toxicity and safety of intradermal fluorescein injections. [ Time Frame: February 2014 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
Drug: Fluorescein
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.
Other Name: Fluorescite®

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  Eligibility

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

Inclusion Criteria:

  1. Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
  2. Between 18 and 90 years of age.
  3. Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues)
  4. Have a primary melanoma meeting one of the following criteria:

    1. Primary melanoma was ≥ 0.75 mm Breslow thickness and Clark level III or
    2. Primary melanoma was Clark level IV/V or
    3. Primary melanoma was ulcerated or
    4. Primary tumor mitotic >1/mm2 or
    5. 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
    6. Have had a prior excision (non-wide local excision) of a melanocytic lesion with development of a primary melanoma in the excision scar or
    7. 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
  5. Clinically negative lymph nodes.
  6. ECOG performance status 0-1

Exclusion Criteria:

  1. Primary melanoma of the eye, mucous membranes or internal viscera.
  2. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional or distant metastatic disease.
  3. 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.
  4. Allergy to radiocolloid or fluorescein.
  5. 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.)
  6. 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.
  7. 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.
  8. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
  9. Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
  10. History of organ transplantation.
  11. Pregnant or lactating women.
  12. Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
  13. 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.
  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: NCT00847522

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Robert H Andtbacka, MD Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00847522     History of Changes
Other Study ID Numbers: HCI26818
Study First Received: February 17, 2009
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
melanoma
skin cancer
lymph node
sentinel lymph node
malignant melanoma
mapping

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 28, 2014