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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01266096
First received: December 21, 2010
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Newly Diagnosed or Recurrent Metastatic Melanoma Patients
Malignant Brain Tumors
Drug: PET scan with 124I-cRGDY-PEG-dots

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots† [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 11
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: newly diagnosed or recurrent head/neck melanoma
This is a two-year microdosing study that will enroll 5 metastatic melanoma and up patients to 6 brain tumor patients at MSKCC who have either have a high grade glioma (n=3) or brain metastases (n=3) from melanoma, non-small cell lung carcinoma, or other non-CNS primary lesion. 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 up to six (6) 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 GE STE PET/CT scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266096

Contacts
Contact: Michelle Bradbury, MD, PhD 646-888-3373
Contact: Snehal Patel, MD 212-639-3412

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michelle Bradbury, MD, PhD    646-888-3373      
Principal Investigator: Michelle Bradbury, MD, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michelle Bradbury, MD,PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01266096     History of Changes
Other Study ID Numbers: 10-155
Study First Received: December 21, 2010
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
124I-cRGDY-PEG-dots
Pet scan
10-155
melanoma
brain

Additional relevant MeSH terms:
Brain Neoplasms
Melanoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 20, 2014