PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study

Recruitment & Eligibility

Inclusion Criteria

18 years of age or older
Histologically confirmed diagnosis of melanoma or malignant brain tumor at MSKCC
Newly-diagnosed or recurrent (local,regional, metastatic) metastatic melanoma or malignant brain tumor patients with
Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas or malignant brain tumor
Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
Newly diagnosed patients with previous excisional biopsy.
Normal baseline cardiac function based upon pre-operative evaluation
At the discretion of the physician ANC>1000/mcl and platelets>100,000/mcl.
At the discretion of the physician Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
If patients have a history of malignancy other than melanoma or malignant brain tumor they must be disease-free (excluding primary cancer for metastatic patients) for ≥ 5 years at the time of enrollment.
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

Abnormal thyroid function, such as untreated clinical diagnosis of hypothyroidism, hyperthyroidism, or other thyroid disease
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 tracer. 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.
History of any malignancy (excluding primary cancer for metastatic patients) other than melanoma or malignant brain tumors for which the disease-free interval is <5 years.
Allergic reaction to iodine-containing contrast material
Weight greater than the 400-lb weight limit of the PET scanner
Claustrophobia
Inability to lie in the scanner for 30 minutes

Study & Design

Arm && Interventions

Group	Intervention	Description
newly diagnosed or recurrent head/neck melanoma	PET scan with 124I-cRGDY-PEG-dots	This is a two-year microdosing study that will enroll 5 metastatic melanoma patients and 18 malignant brain tumor patients (surgical (n=13) and non-surgical candidates (n=5)). We have already accrued 5 melanoma patients and expect to accrue brain tumor patients within a 1 year period.

Primary Outcome Measures

Name	Time	Method
Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†	2 years	in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.

Secondary Outcome Measures

Name	Time	Method
Assay particle tracer tissue distributions in tumor tissue specimens	2 years
Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots.	1 year	studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects

Recruitment & Eligibility