Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02058953 : CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases
Phase
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02058953      |      Link to official Clinicaltrials.gov listing
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