Metastatic Melanoma Clinical Trial
Official title:
Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Serum/Plasma From Patients With Metastatic Melanoma to the CNS and Respective Controls for Gene Expression and Proteomic Profiling
Verified date | July 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
This study has two ultimate goals:
1. Understand how the original melanoma from the skin spreads to the CNS. In order to
study this we need to collect (and compare) the original skin melanoma, the CNS
melanoma, as well as any other melanoma that has not metastasized to the CNS.
2. Develop a diagnostic blood test that will early identify subjects at high risk for
developing CNS metastasis or patients who may already have CNS metastasis but the MRI
or the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from
subjects like you who have melanoma CNS metastases in order to confirm the presence of
this biomarker.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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 and be able to undergo lumbar puncture for CSF collection - Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable if documented from a previous visit within the prior 30 days - Subjects must have provided written, informed consent (ICF) prior to any study procedures - Subjects must provide a FFPE tissue block containing a biopsy from the primary site 2. 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 must have no contraindications for and be able to undergo lumbar puncture for CSF collection - Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable if documented from a previous visit within the prior 30 days - Subjects must have provided written ICF prior to any study procedures 3. Regarding patients who have distant metastatic melanoma without radiographically detectable melanoma CNS metastases but are willing to undergo lumbar puncture: - Histologically confirmed melanoma (unknown primary, mucosal, ocular are allowed), - Patients must have no contraindications to lumbar puncture - Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable, if documented from a previous visit within the prior 30 days - Subjects must have provided written ICF prior to any study procedures 4. Regarding healthy volunteers - Patients must have no contraindications to lumbar puncture (see Table 1) - Patient must answer NO to all questions listed in Appendix B - Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent or will be acceptable if documented from a previous visit within the prior 30 days - Subjects must have provided written, ICF prior to any study procedures 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. - Patients with new focal findings on neurological examination. - Infected skin over the lumbar puncture needle entry site. - Other conditions that at the opinion of the investigator are contraindicated. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
Recruiting |
NCT05388877 -
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
|
Phase 1 | |
Active, not recruiting |
NCT05103891 -
Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations
|
Phase 1 | |
Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Completed |
NCT01621490 -
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
|
Phase 1 | |
Recruiting |
NCT05779423 -
Cryoablation+Ipilimumab+Nivolumab in Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT02278887 -
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT02360579 -
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT02521870 -
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02177110 -
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
|
||
Withdrawn |
NCT01340729 -
Open-Label Study of TPI 287 for Patients With Metastatic Melanoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01416844 -
Study of Immune Responses in Patients With Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT01468818 -
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00984464 -
Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00631618 -
Clinical Trial of Sutent to Treat Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT00571116 -
Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy
|
Phase 1 | |
Recruiting |
NCT00226473 -
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
|
Phase 4 |