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Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients
Conditions
Head and Neck Cancer - Melanoma - Prostate Cancer - Cervical Cancer - Uterine Cancer
Conditions: official terms
Head and Neck Neoplasms - Melanoma - Uterine Cervical Neoplasms - Uterine Neoplasms
Conditions: Keywords
Sentinel Lymph Node Mapping, Intraoperative Sentinel, Head and Neck, Targeted Silica Nanoparticles, cRGDY-PEG-Cy5.5-C dots, 13-249
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: fluorescent cRGDY-PEG-Cy5.5-C dots
Type: Drug
Overall Status
Recruiting
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"). This is a pilot study, containing a total of 30 patients. There will be 10 patients from each of three groups. The groups are for head and neck melanoma, cervical/uterine, and prostate cancers. As a part of the standard of care, the they will initially undergo imaging of their lymph nodes prior to their surgery. Melanoma 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 cervical or uterine 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. For prostate cancer patients, this is the only injection they will receive. 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. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- 18 years of age or older
- Histologically confirmed diagnosis of melanoma, uterine or cervical, or prostate cancer at MSKCC
- Have one of the following disease histories:
- Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma 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 uterine or cervical cancer patients in whom SLN mapping and surgical excision is indicated OR
- Newly-diagnosed prostate cancer with nomogram predicted risk of lymph node invasion of 2% or greater
- Normal baseline cardiac function based upon pre-operative evaluation
- 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).
- 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.
- 18 years of age or older
- Histologically confirmed diagnosis of melanoma, uterine or cervical, or prostate cancer at MSKCC
- Have one of the following disease histories:
- Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma 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 uterine or cervical cancer patients in whom SLN mapping and surgical excision is indicated OR
- Newly-diagnosed prostate cancer with nomogram predicted risk of lymph node invasion of 2% or greater
- Normal baseline cardiac function based upon pre-operative evaluation
- 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).
- 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.
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Michelle Bradbury, MD, PhD - 646-888-3373
Start Date
April 2014
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page