CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases

Melanoma Clinical Trial

— 13-052  

Official title:

Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Blood From Patients With Melanoma Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058953
• Other study ID #: UPCI 13-052 (IMWG-01)
• Status: Completed
• Start date: August 12, 2014
• Est. completion date: August 19, 2019

Study information

• Verified date: October 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Melanoma
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• Craniotomy scheduled
Resection of affected brain tissue
• Collection for non-craniotomy
CSF, Blood, biopsy

Locations

Country	Name	City	State
Australia	Melanoma Institute Australia- Westmead Institute for Cancer Research	Sydney
United States	The University of Texas- MD Anderson Cancer Center	Houston	Texas
United States	University of Pittsburgh Medical Center- Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood, tumor tissue samples and adjacent uninvolved tissue and Cerebrospinal Fluid	Collection of these samples to help determine: if CNS melanoma metastases are similar to primary cutaneous melanomas, and assist in efforts to develop biomarkers that predict development of CNS melanoma metastases from the cutaneous primary lesion; or if CNS melanoma metastases are similar to extracranial metastases, and assist in efforts to develop effective systemic therapies for extracranial MM that also take into account the molecular profile of CNS melanoma metastases would more likely have an impact upon development of CNS melanoma metastases.	2 years