Melanoma13-052NCT02058953
CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases
An observational study of Melanoma and Brain Metastases, run by University of Pittsburgh at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Brain Metastases
- What is being tested?
- Craniotomy scheduled and Collection for non-craniotomy
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Aug 2014to 19 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy-proven melanoma who present with melanoma CNS metastases, a condition that has been previously either biopsy-proven or there is strong suspicion based on the radiologic imaging (brain MRI or brain CT with intravenous contrast) will be considered for the study.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The University of Texas- MD Anderson Cancer Center
Houston, Texas, 77030
University of Pittsburgh Medical Center- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Australia1 site
Melanoma Institute Australia- Westmead Institute for Cancer Research
Sydney
About this study
Official title: Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, 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.
Read the detailed 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.
- Conditions
- Melanoma, Brain Metastases
- Being tested
- Craniotomy scheduled, Collection for non-craniotomy
- Keywords
- Melanoma, skin cancer, brain metastases, craniotomy
- Medical subject headings
- Melanoma, Brain Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniotomy scheduledProcedure or surgery
Resection of affected brain tissue
Collection for non-craniotomyProcedure or surgery
CSF, Blood, biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Craniotomy scheduled | |
| 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 Receives: Procedure: Collection for non-craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start12 Aug 2014
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, John Kirkwood, University of Pittsburgh
- Investigators
- John Kirkwood, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058953
- Sponsor's protocol ID
- UPCI 13-052 (IMWG-01)
- Acronym
- 13-052
- Status last verified
- Oct 2019
- First submitted
- 6 Feb 2014
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Blood From Patients With Melanoma Brain Metastases
- ClinicalTrials.gov ID
- NCT02058953
- Acronym / sponsor ID
- 13-052 / UPCI 13-052 (IMWG-01)
- Conditions
- Melanoma, Brain Metastases
- Keywords
- Melanoma, skin cancer, brain metastases, craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Craniotomy scheduled | – | Procedure: Craniotomy scheduledPatients 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 | – | Procedure: Collection for non-craniotomyFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-proven melanoma who present with melanoma CNS metastases, a condition that has been previously either biopsy-proven or there is strong suspicion based on the radiologic imaging (brain MRI or brain CT with intravenous contrast) will be considered for the study.
Key inclusion criteria (14 listed)
- 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:
- 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):
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniotomy scheduledResection of affected brain tissue | Procedure or surgery | Craniotomy scheduled |
| Collection for non-craniotomyCSF, Blood, biopsy | Procedure or surgery | Collection for non-craniotomy |
Primary outcome
Collection of blood, tumor tissue samples and adjacent uninvolved tissue and Cerebrospinal Fluid
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kirkwood, MD principal investigator
University of Pittsburgh Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Brain Metastases, run by University of Pittsburgh at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of blood, tumor tissue samples and adjacent uninvolved tissue and Cerebrospinal Fluid (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.