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Investigator(s):
Susan Bates, M.D. Principal Investigator Phone: 301-402-5958 sebates@helix.nih.gov	Laleh Amiri-Kordestani, M.D. Associate Investigator Phone: 301-402-5958 amirikordestal@mail.nih.gov
Referral Contact(s):
Christine Bryla, R.N., M.S.N Research Nurse Phone: 301-451-7868 brylacm@mail.nih.gov	Robin Frye, R.N., B.S.N. Research Nurse Phone: 301-402-5958 Fax: 301-496-9781 fryer@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) that has spread to the brain
• Presence of resectable brain metastases with or without prior radiotherapy*
• Able to undergo an MRI and FLT-PET
• At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose GRN1005
• Neurologically stable: On a stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbital, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
• Karnofsky performance status of ≥ 70 percent (ECOG ≤ 1)
• No CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.), known leptomeningeal disease, or neuropathy ≥ grade 2

* Patients must be greater than 28 days from whole-brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS)

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Study Outline:

• Screening physical examination, blood and urine samples and imaging studies to determine eligibility for the study; tumor tissue samples may also be collected
• Patients with lung cancer will receive GRN1005
• Patients with breast cancer will be placed in one of two groups depending on their type of breast cancer:
• Those whose cancer contains the HER2 protein will be treated with the drug trastuzumab as well as GRN1005
• Those without HER2 will receive GRN1005 alone
• All participants will have two doses of GRN1005, each 3 weeks apart
• On the day that the second dose of GRN1005 is given, participants will undergo surgery to remove the brain tumors
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies during treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.

Reviewed: 9/12/12
Updated: 9/12/12