Patient case: 64-year-old male with melanoma; genetic feature: BRAF (V600E)

Clinical trial: Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Breast and Gynecologic Malignancies

Summary: 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"). The groups are for head and neck melanoma, gynecologic, 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. For gynecologic 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.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Histologically confirmed diagnosis of melanoma, breast cancer or gynecologic 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 gynecologic cancer patients in whom SLN mapping and surgical excision is indicated OR
  -  Normal baseline cardiac function based upon pre-operative evaluation
  -  At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.
  -  At the discretion of the operating surgeon, 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.

Relevance to patient case: not relevant