Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02106598
First received: April 3, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

Current imaging devices usually detect cancer prior to surgery. However, these devices cannot be used during the surgical procedure to visualize lymph nodes with cancer (called "sentinel lymph nodes"). As a part of the standard of care, the patient will initially undergo imaging of their lymph nodes prior to their surgery. They will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours later using a device to image where the dye travels to in the neck. In addition, we will test, for the first time in humans, a new, experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This particle, the size of a small protein, will be injected around sites of melanoma in the operating room to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. The particles will not treat the cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.


Condition Intervention Phase
Melanoma
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility of conducting pre-operative SLN mapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    using real-time optical detection procedures and intradermal single- or double-dose injection/s of non-radioactive cRGDY-PEG-Cy5.5-C dots about the primary tumor site. Feasibility will be determined on the basis of achieving adequate image contrast for detection, as defined by signal-to-background ratios, and whether optical signal distinguishes diseased SLNs from non-diseased ones


Estimated Enrollment: 10
Study Start Date: April 2014
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Head and Neck Melanoma Patients
preoperatively administered technetium-99m (99mTc) sulfur colloid with intraoperatively injected fluorescent cRGDY-PEG-Cy5.5-C dots (0.1 - 0.5 ml over a dose range of ~0.25 to ~1.2 nanomoles in 4 quadrants about the primary lesion) for identification of sentinel nodes. Intraoperative NIR fluorescence imaging will be performed using a state-of-the-art hand-held fluorescence camera system (f 2.4) for real-time optical visualization of nodal disease, along with gamma counting for 99mTc sulfur colloid, to determine if concordance can be established as a continuous endpoint. Results will be histologically confirmed in resected tissue specimens.
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed diagnosis of melanoma at MSKCC
  • Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma patients in whom SLN mapping is indicated
  • Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas
  • Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
  • Newly diagnosed patients with previous excisional biopsy. Normal baseline cardiac function based upon EKG and pre-operative evaluation
  • ANC>1000/mcl and platelets>100,000/mcl.
  • Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
  • If patients have a history of malignancy other than melanoma, they must be disease-free for ≥ 5 years at the time of enrollment.
  • All patients of childbearing and child-creating age must be using an acceptable form of birth control
  • Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria:

  • Known pregnancy or breast-feeding.
  • Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.
  • History of any malignancy other than melanoma for which the disease-free interval is <5 years and/or on active therapy for that malignancy.
  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: NCT02106598

Contacts
Contact: Michelle Bradbury, MD, Phd 646-888-3373
Contact: Snehal Patel, MD 212-639-3412

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michelle Bradbury, MD, PhD    646-888-3373      
Contact: Snehal Patel, MD    212-639-3412      
Principal Investigator: Michelle Bradbury, MD, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michelle Bradbury, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02106598     History of Changes
Other Study ID Numbers: 13-249
Study First Received: April 3, 2014
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Sentinel Lymph Node Mapping
Intraoperative Sentinel
Head and Neck
Targeted Silica Nanoparticles
cRGDY-PEG-Cy5.5-C dots
13-249

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 23, 2014