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


N/A
18 Years
N/A
Open (Enrolling)
Both
Newly Diagnosed or Recurrent Metastatic Melanoma Patients, Malignant Brain Tumors

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Trial Information

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


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 EKG and 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).

- If patients have a history of malignancy other than melanoma or malignant brain tumor
they must be disease-free 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:

- 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†

Outcome Description:

in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michelle Bradbury, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-155

NCT ID:

NCT01266096

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Newly Diagnosed or Recurrent Metastatic Melanoma Patients
  • Malignant Brain Tumors
  • 124I-cRGDY-PEG-dots
  • Pet scan
  • 10-155
  • melanoma
  • brain
  • Brain Neoplasms
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021