Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Breast and Cervical/Uterine Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: March 14, 2016
Last verified: March 2016
  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"). This is a pilot study, containing a total of 45 patients. There will be 15 patients from each of three groups. The groups are for head and neck melanoma, cervical/uterine, and breast cancers. As a part of the standard of care, the they will initially undergo imaging of their lymph nodes prior to their surgery. Melanoma and breast cancer patients will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours the location of the later using a device to image the dye. Breast cancer patients will also be injected with a blue dye in the operating room. For cervical or uterine cancer patients, they will be injected with a indocyanine green in the operating room and then images will be acquired soon after. In addition, the investigators 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 before or during your surgery to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. Based upon the clinical diagnosis, the patient may have a procedure called Reverse Lymphatic Mapping, which is a new form of sentinel lymph node mapping. The doctor will discuss this with the patient. If the patient is undergoing reverse lymphatic mapping, they will have the experimental particle injected into their hand or foot (based on their tumor type) and the standard of care injection will be injected around the tumor. This will allow the surgeon to remove only the lymph nodes that directly link to the 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
Head and Neck Cancer
Melanoma
Breast Cancer
Cervical Cancer
Uterine Cancer
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots
Phase 1

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, Breast and Cervical/Uterine Cancer 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: 45
Study Start Date: April 2014
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Head & Neck Melanoma,Breast, Uterine & Cervical Patients
Patient will initially undergo routine imaging 0.5 - 2 hrs after local injection of 99mTc-technetium sulfur colloid of Lymphoseek® per the standard procedure. Up to 24 hours prior to surgery or in the operative suite, intradermal, 4-quadrant injections of cRGDY-PEG-Cy5.5-C dots will be administered as a single or multiple doses about the tumor site. Uterine & cervical patients,indocyanine green( ICG) will be injected in the OR suite. In patients undergoing reverse lymphatic mapping, & at the discretion of the operating surgeon, ICG & cRGDY-PEG-Cy5.5-C dots will be injected intraoperatively - one peritumorally & one intradermally within the corresponding ipsilateral extremity. Patient's optical scans will be acquired in the surgical suite using the Quest Spectrum TM portable two-fluorescence channel camera system (f 2.4; 15 frames per second; resolution 50 um) & video monitoring. In the operating room, vital signs will be monitored per routine prior to & after agent administration.
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, breast cancer or uterine or cervical, or prostate cancer at MSKCC
  • Have one of the following disease histories:
  • Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma or breast cancer 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. OR
  • Newly-diagnosed uterine or cervical cancer patients in whom SLN mapping and surgical excision is indicated OR
  • Normal baseline cardiac function based upon 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).
  • For melanoma patients, If patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.
  • 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.
  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, FRCS 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, FRCS    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:
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: March 14, 2016
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:
Head and Neck Neoplasms
Melanoma
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on April 27, 2016