CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases
CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases
The purpose of this study is to collect and bank samples of blood and tissues (such as brain
 tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes
 and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples.
 The investigator hopes that by studying the biomarkers, he can develop tests in the future
 that can detect central nervous system (CNS) metastasis in blood samples before they show up
 on x-ray and develop medicines that can specifically target CNS metastasis.
Among the different sites to which melanoma can spread, the Central Nervous System (CNS) has
 the highest chance of developing metastases. Prognosis for metastatic melanoma involving the
 CNS is worse than that of CNS metastases from other cancers. Therefore, it is felt that early
 identification of this condition, even before it is found on x-ray (either MRI or CT scan),
 would be beneficial so that patients can undergo treatment earlier.

 The investigator hypothesizes that the tumor cell genetics, expressed proteins, and/or
 signaling pathways of melanoma brain metastases may exhibit features that distinguish
 melanoma brain metastases. The investigator further hypothesizes that melanoma brain
 metastases may be associated with changes in the cerebrospinal fluid, where protein fragments
 expressed by melanoma brain metastases may be shed that cannot be found in normal CNS
 tissues, extracranial metastases (MEM) or at the same levels in the peripheral blood.
Inclusion Criteria:

 -  Subjects must have provided written Informed Consent prior to any study procedure.

 -  Regarding patients with distant metastatic melanoma and established melanoma CNS
 metastases who are scheduled for craniotomy:

 -  Histologically confirmed, primary cutaneous melanoma, metastatic to the CNS
 (brain OR spinal cord OR carcinomatous meningitis) based on:

 -  Pathologic confirmation (i.e. prior craniotomy) OR

 -  Radiography (brain MRI or CT scan with intravenous contrast)

 -  Patients must have no contraindications for lumbar puncture for CSF collection

 -  Hemoglobin level of 8g/dL or higher within the prior 30 days

 -  FFPE tissue block containing a biopsy from the primary site available for
 retrieval.

 -  Regarding patients with distant metastatic melanoma and established melanoma CNS
 metastases who are not having a craniotomy and before they undergo external beam
 irradiation or stereotactic radiosurgery (patient's and/or neurosurgeon's preference):

 -  Histologically confirmed melanoma (unknown primary, mucosal, ocular are allowed),
 metastatic to the CNS (brain OR spinal cord OR carcinomatous meningitis) based on

 -  Pathologic confirmation (i.e. prior craniotomy) and/or

 -  Radiography (brain MRI or CT scan with intravenous contrast)

 -  Patients without contraindications to undergo lumbar puncture for the component
 that relates to CSF collection as determined by the neurosurgeon. An external
 ventricular drain (EVD) may be utilized if clinically indicated and the source of
 CSF (LP or EVD) clearly recorded (this is not required for enrollment in the
 overall protocol if there are any contra-indications to performance of this
 procedure)

 -  Hemoglobin level of 8g/dL or higher within the prior 30 days

 Exclusion Criteria:

 -  For study subjects, patients with extradural lesions, i.e. those that originate from
 the bone (calvarium or vertebrae), will not be considered.

 -  Any significant psychiatric disease, medical intervention, or other conditions, which
 in the opinion of the Investigators, could impair proper discussion of the informed
 consent or compromise participation to the clinical trial.

 -  Active systemic treatment for metastatic melanoma within 2 days from the collection of
 specimens (brain tumor tissue, peripheral blood, CSF). Corticosteroids, other
 immunosuppressive anti-inflammatory and anti-epileptic medications are allowed.

 -  Patients who have undergone whole brain irradiation therapy within the last 30 days.
 Therefore neither CNS lesions nor CSF are considered suitable for collection.

 -  Patients with growing CNS lesions at an area that has previously undergone
 radiosurgery within 3 months prior to enrollment in this study. Therefore CNS tumors
 from previously irradiated areas using radiosurgery are not considered suitable for
 collection although CSF is allowed for collection.

 -  Brain abscess.

 -  Other conditions that at the opinion of the investigator are contraindicated.