What side effects are associated with this type of intervention?

Common treatments for melanoma include immunotherapy, targeted therapy, and chemotherapy. Immunotherapy, such as checkpoint inhibitors (e.g., nivolumab, pembrolizumab), can cause side effects like fatigue, rash, diarrhea, and immune-related adverse events affecting organs like the lungs, liver, and endocrine glands. Targeted therapies (e.g., BRAF and MEK inhibitors) often lead to side effects such as skin rash, fever, fatigue, and joint pain. Chemotherapy, though less commonly used, can cause nausea, vomiting, hair loss, and increased risk of infection. Each treatment has a unique side effect profile, and patients should discuss these with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma, including targeted therapies and immunotherapies. While specific dye-labeled particles like cRGDY-PEG-Cy5.5-C dots for improved visualization of cancerous lymph nodes are still under investigation, other imaging agents and targeted therapies have been approved. For instance, the FDA has approved the use of pembrolizumab (Keytruda) and nivolumab (Opdivo), which are immune checkpoint inhibitors that help the immune system recognize and attack melanoma cells. Additionally, targeted therapies such as vemurafenib (Zelboraf) and dabrafenib (Tafinlar) target specific genetic mutations in melanoma cells. These treatments have significantly improved the management of melanoma, although the specific use of dye-labeled particles for intraoperative mapping remains an area of active research.

What other types of research exist?

Promising alternatives to cRGDY-PEG-Cy5.5-C dots for melanoma patients include: 1) Functionalized amino-PEG quantum dots conjugated to DUPA targeted polypeptide constructs, which have shown high specificity and deep tissue penetration in prostate cancer models. 2) Chitosan-coated PLGA particles, which have demonstrated improved persistence in tumors and effective imaging capabilities in vivo. 3) c(RGDyk)-modified nanoparticles encapsulating quantum dots, designed for imaging-guided surgical resection of gliomas, which offer good stability and lower toxicity.

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Silica Nanoparticles for Head and Neck Cancer Imaging

Phase 1 & 2

Waitlist Available

Led By Hilda Stambuk, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Histologically confirmed diagnosis of melanoma at MSKCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new dye-labeled particle to help doctors see cancerous lymph nodes during surgery in patients with head and neck cancer. The particles are injected around the tumor and light up under a special camera, making it easier to identify affected areas. This method aims to improve current imaging techniques by using recent innovations in imaging technology.

Who is the study for?

This trial is for adults with newly diagnosed or recurrent melanoma, oral cavity squamous cell carcinoma, and skin squamous cell carcinoma needing lymph node mapping. Participants must use birth control if applicable and have normal organ function as determined by the physician. Those who've had recent heart issues, uncontrolled infections, or are pregnant/breastfeeding cannot join.

What is being tested?

The study tests a new imaging agent called cRGDY-PEG-Cy5.5-C dots in 67 patients to see if it can better identify cancerous lymph nodes during surgery compared to standard scans. This agent isn't FDA-approved yet and won't be used for treatment but may inform future research.

What are the potential side effects?

Since this is an investigational imaging agent not intended for treatment, specific side effects aren't detailed here; however, potential risks could include allergic reactions to the dye or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My melanoma diagnosis was confirmed through tissue examination at MSKCC.

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I was recently diagnosed and had a lump removed for testing.

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I still have visible tumor signs after initial treatment.

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I need flap reconstruction in my head or neck after previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

feasibility of conducting pre-operative SLN mapping

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 2 - Head and Neck CancerExperimental Treatment1 Intervention

Patients with early oral cavity squamous cell carcinoma, and prior to standard of care wide local resection of the primary tumor and elective neck dissection, will receive a locally-administered, peritumoral injection of fluorescent cRGDY-PEG-Cy5.5-C dots (0.25 - 1 ml) around the primary lesion while under standard-of-care anesthesia for identification of optically-avid SLNs and to assess for metastatic disease. After completion of the neck dissection, nodal specimens will be examined ex vivo for fluorescence signal. Any fluorescent and non-fluorescent nodes will be compared to determine the true positive and false positive rates for cancer detection in this pilot study. No change in standard of care surgical practice will occur.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma include immunotherapy, targeted therapy, and photodynamic therapy. Immunotherapy, such as anti-PD-1 or anti-CTLA-4 antibodies, works by enhancing the body's immune response to target and destroy cancer cells. Targeted therapy involves drugs that specifically inhibit mutations in melanoma cells, such as BRAF or MEK inhibitors, thereby blocking cancer cell growth. Photodynamic therapy uses light-activated drugs to produce reactive oxygen species that kill cancer cells. The cRGDY-PEG-Cy5.5-C dots trial, which uses dye-labeled particles for better visualization of cancerous lymph nodes, highlights the importance of precise detection and treatment of melanoma. Improved visualization aids in accurate staging and surgical removal, ultimately enhancing treatment outcomes for melanoma patients.

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