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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02058953




Registration number
NCT02058953
Ethics application status
Date submitted
6/02/2014
Date registered
11/02/2014

Titles & IDs
Public title
CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases
Scientific title
Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Blood From Patients With Melanoma Brain Metastases
Secondary ID [1] 0 0
UPCI 13-052 (IMWG-01)
Universal Trial Number (UTN)
Trial acronym
13-052
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Brain Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Craniotomy scheduled
Treatment: Surgery - Collection for non-craniotomy

Craniotomy scheduled - Patients who have scheduled craniotomy with melanoma brain metastases will have the following specimens collected:

1. CNS tumor specimens, specifically the remaining portion from the resected melanoma CNS metastasis
2. the remaining portion from the adjacent "normal" CNS tissue. No additional normal brain tissue will be collected for research purposes only, however the routinely collect peritumoral tissue will be retained.
3. melanoma specimens from other extracranial, clinically palpable metastatic sites.
4. CSF taken at around the time of the craniotomy procedure
5. peripheral blood prior to craniotomy.

Collection for non-craniotomy - For those eligible patients who are not having a craniotomy:

1. collection of CSF will be performed by lumbar puncture or from the patient's Ommaya reservoir, if present.
2. collection of peripheral blood.

NOTE: Only patients who have no absolute contraindications or up to two relative contraindications will be considered for lumbar puncture


Treatment: Surgery: Craniotomy scheduled
Resection of affected brain tissue

Treatment: Surgery: Collection for non-craniotomy
CSF, Blood, biopsy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Collection of blood, tumor tissue samples and adjacent uninvolved tissue and Cerebrospinal Fluid
Timepoint [1] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2019
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melanoma Institute Australia- Westmead Institute for Cancer Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pittsburgh
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Kirkwood, MD
Address 0 0
University of Pittsburgh Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02058953