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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01057 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study is being done to evaluate the toxicity and safety of carboplatin administered by convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This study is a dose escalating study, (the dose of the study drug is increased at set time points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows or stops the growth of cancer cells in your body. Convection enhanced delivery involves placing one or more catheters into the brain and delivering chemotherapy through those catheters directly into the brain
PRIMARY OBJECTIVES:
I. Establish the maximum tolerated dose and define the toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms.
SECONDARY OBJECTIVES:
I. Examine the efficacy as defined by six-month progression free survival (PFS), median progression free survival, overall survival, and the radiographic response rate.
II. Evaluate the drug distribution.
OUTLINE: This is a phase I, dose-escalation study.
Patients undergo craniotomy and then receive carboplatin intracerebrally via convection-enhanced delivery (CED) over 72 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (carboplatin) | Experimental | Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room and then receive carboplatin administered intracerebrally by convection enhanced delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish maximum tolerated dose and define toxicity profile | The toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms. The maximum tolerated dose (MTD) of infused carboplatin may then be incorporated into future clinical studies. | 72 hours after maximal medical therapy is initiated |
| Measure | Description | Time Frame |
|---|---|---|
| Six month progression free survival defined as the proportion of patients with stable disease at 6 months from surgery | Time between surgery and earliest sign of disease progression or death, assessed up to 6 months | |
| Median progression free survival | Time between surgery and earliest sign of disease progression or death, assessed up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Elder | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013514 | Surgical Procedures, Operative |
| D003399 | Craniotomy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D019635 | Neurosurgical Procedures |
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| Surgery | Procedure | Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room. |
|
|
| Radiographic response rate | Up to 2 years |
| Overall survival | Time from surgery until death, assessed up to 2 years |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |