Targeted Silica Nanoparticles in Imaging Sentinel Lymph Nodes in Patients with Newly-Diagnosed and / or Recurrent Melanoma or Oral Cavity Squamous Cell Cancer

This phase I / II trial studies how well targeted silica nanoparticles work in imaging lymph nodes in patients with melanoma or oral cavity squamous cell that has come back (recurrent) and / or is newly-diagnosed. During surgery, it can be difficult to visualize nodes with cancer called sentinel lymph nodes. Targeted silica nanoparticles can be used to detect disease that has spread to local / regional nodes and allow the surgeon to remove the sentinel lymph nodes without harming normal lymph nodes.

Inclusion Criteria

• Histologically confirmed diagnosis of melanoma at Memorial Sloan-Kettering Cancer Center (MSKCC)
• Have one of the following disease histories: * Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma or oral cavity squamous cell carcinoma patients in whom sentinel lymph node (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
• At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
• At the discretion of the physician or surgeon, absolute neutrophil count (ANC) > 1000/mcl
• At the discretion of the physician or surgeon, platelets > 100,000/mcl
• At the discretion of the physician or 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

PRIMARY OBJECTIVES:

I. Determine the proportion of lymph nodes identified by 99mTc sulfur colloid that are positive by cRGDY-PEG-Cy5.5-C dot visualization.

II. Determine the proportion of patients in whom the surgical approach or extent of dissection was altered as a result of cRGDY-PEG-Cy5.5C dot visualization.

III. Determine whether the signal foci visualized optically correspond to lymph nodes or lymphatic channels.

IV. Monitor for adverse reactions to the non-radioactive particle probe as a safety endpoint.

SECONDARY OBJECTIVES:

I. Compare detection rates of cRGDY-PEG-Cy5.5-C dots and Tc99m sulfur colloid for pathology-positive sentinel lymph nodes (SLNs).

II. Correlate optical signal with tumor burden assessments.

III. Assess alpha-v integrin expression levels in primary and nodal tissue specimens derived from a subset of patients.

OUTLINE:

Up to 24 hours before or during surgery, patients receive fluorescent cRGDY PEG-Cy5.5 C dots intradermally (ID) or via intramucosal or periareolar injections.

After completion of study, patients are followed up at 2 weeks.

Trial Phase Phase I/II

Trial Type Diagnostic

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Hilda E Stambuk

• Primary ID 13-249
• Secondary IDs NCI-2016-01052
• Clinicaltrials.gov ID NCT02106598