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 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 patients with oral cavity or cutaneous squamous cell carcinoma in whom SLN mapping is indicated; these patients are clinically node negative by history, physical examination, and imaging ** 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
• Known allergies to polyethylene glycol (PEG)-containing products (bowel preparations, laxatives) or PEG allergy
• 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. Compare the proportion of excised sentinel lymph nodes (SLNs) identified by technetium Tc-99m (99mTc) sulfur colloid with the proportion of excised SLNs identified by cRGDY-PEG-Cy5.5-C dots (efficacy endpoint).

II. Assess the false negative rate, dividing the number of patients with cancer-positive nodes not

detected by cRGDY-PEG-Cy5.5-C dots with those harboring at least one cancer-positive node,

with or without cRGDY-PEG-Cy5.5-C’ dot positivity (efficacy endpoint).

SECONDARY OBJECTIVES:

I. Determine the proportion of lymph nodes detected by cRGDY-PEG-Cy5.5-C dots only, 99mTc-sulfur colloid (SC) only, and neither mapping modality.

II. Determine the patient-level detection rate for 99mTc-SC and cRGDY-PEG-Cy5.5-C dots (i.e. the proportion of patients in whom at least one lymph mode was detected by each modality).

III. Determine the patient-level rate of identifying at least one cancer-positive node by cRGDY-PEG-Cy5.5-C dots referenced to the number of patients with at least one cancer-positive node found at surgery by any method.

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

V. To monitor for adverse reactions to the non-radioactive particle probe (safety endpoint).

VI. To assess whether signal foci visualized optically correspond to nodes or lymphatic channels.

VII. Correlate optical signal with tumor burden assessments.

OUTLINE:

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 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