fluorescent cRGDY-PEG-Cy5.5-C dots for Head and Neck Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Melanomafluorescent cRGDY-PEG-Cy5.5-C dots - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if injecting a dye-labeled particle can help visualize cancerous lymph nodes in head and neck cancer patients. This is to improve upon the current standard of care scans.

Eligible Conditions
  • Head and Neck Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
feasibility of conducting pre-operative SLN mapping

Trial Safety

Trial Design

1 Treatment Group

Phase 2 - Head and Neck Cancer
1 of 1

Experimental Treatment

86 Total Participants · 1 Treatment Group

Primary Treatment: fluorescent cRGDY-PEG-Cy5.5-C dots · No Placebo Group · Phase 1 & 2

Phase 2 - Head and Neck Cancer
Drug
Experimental Group · 1 Intervention: fluorescent cRGDY-PEG-Cy5.5-C dots · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,389 Total Patients Enrolled
Hilda Stambuk, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
You have a newly-diagnosed or recurrent malignant melanoma, oral cavity squamous cell carcinoma, or squamous cell carcinoma of the skin patient in whom SLN mapping is indicated.
The tumor must be clinically or radiographically evident.
You have had prior radiation therapy, chemotherapy, or surgery in the head and neck region.
The patient must be in good health and free of cardiac disease.
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).