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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01266096

Collaborator

(none)

Enrollment

Location

Arm

155

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use special dyes that are injected into a vein and can better localize possible cancer. The investigators have developed a new particle that can carry a radioactive dye to a very specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas of possible disease. This particle has been studied in mice and was safe.

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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed or Recurrent Metastatic Melanoma Patients Malignant Brain Tumors	Drug: PET scan with 124I-cRGDY-PEG-dots	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: newly diagnosed or recurrent head/neck melanoma 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.	Drug: PET scan with 124I-cRGDY-PEG-dots Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.

Arm

Intervention/Treatment

Experimental: newly diagnosed or recurrent head/neck melanoma

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.

Drug: PET scan with 124I-cRGDY-PEG-dots

Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.

Outcome Measures

Primary Outcome Measures

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

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
Assay particle tracer tissue distributions in tumor tissue specimens [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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