Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074178
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2003-12-10
Brief Title:
Methotrexate Cyclophosphamide and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Combination Chemotherapy Methotrexate Cyclophosphamide And Etoposide Phosphate Delivered In Conjunction With Osmotic Blood-Brain Barrier Disruption BBBD With Intraventricular Cytarabine - Intra-Ocular Chemotherapy In Patients With Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Protocol-B
Brief Summary:
RATIONALE Drugs used in chemotherapy such as methotrexate cyclophosphamide etoposide phosphate dexamethasone and cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain Giving methotrexate cyclophosphamide and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of giving methotrexate cyclophosphamide and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of giving methotrexate cyclophosphamide and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and efficacy of methotrexate cyclophosphamide and etoposide phosphate administered in conjunction with osmotic blood-brain barrier disruption and dexamethasone and cytarabine in patients with primary CNS lymphoma
Secondary
Determine the ability to recruit an adequate number of patients for this study
Compare progression-free and dementia-free survival with standard measures of overall survival progression-free survival disease-free survival complete response rate cognitive function and quality of life of patients treated with this regimen
Determine the feasibility of conducting a future phase III study of this treatment regimen in this patient population
Correlate neuropsychological outcomes with neuroimaging MRI outcomes in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive methotrexate MTX intra-arterially over 10 minutes cyclophosphamide IV over 10 minutes and etoposide phosphate IV over 10 minutes on days 1 and 2 in conjunction with osmotic blood-brain barrier disruption Patients also receive oral dexamethasone every 6 hours on days 2-15 followed by a taper and intraventricular or intrathecal cytarabine on day 14 Beginning 48 hours after the last dose of MTX patients receive filgrastim G-CSF subcutaneously once daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
NOTE Alternatively patients may receive a single dose of pegfilgrastim administered 24 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive MTX intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam and then weekly for 1 month and monthly for 1 year
Quality of life is assessed at baseline at 6 months at the completion of treatment and then every 6 months for 2 years and annually thereafter
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 3 years
Primary
Determine the toxicity and efficacy of methotrexate cyclophosphamide and etoposide phosphate administered in conjunction with osmotic blood-brain barrier disruption and dexamethasone and cytarabine in patients with primary CNS lymphoma
Secondary
Determine the ability to recruit an adequate number of patients for this study
Compare progression-free and dementia-free survival with standard measures of overall survival progression-free survival disease-free survival complete response rate cognitive function and quality of life of patients treated with this regimen
Determine the feasibility of conducting a future phase III study of this treatment regimen in this patient population
Correlate neuropsychological outcomes with neuroimaging MRI outcomes in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive methotrexate MTX intra-arterially over 10 minutes cyclophosphamide IV over 10 minutes and etoposide phosphate IV over 10 minutes on days 1 and 2 in conjunction with osmotic blood-brain barrier disruption Patients also receive oral dexamethasone every 6 hours on days 2-15 followed by a taper and intraventricular or intrathecal cytarabine on day 14 Beginning 48 hours after the last dose of MTX patients receive filgrastim G-CSF subcutaneously once daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
NOTE Alternatively patients may receive a single dose of pegfilgrastim administered 24 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive MTX intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam and then weekly for 1 month and monthly for 1 year
Quality of life is assessed at baseline at 6 months at the completion of treatment and then every 6 months for 2 years and annually thereafter
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-5729-2 | OTHER | OHSU IRB legacy number | None |
| 5729-2 | OTHER | None | None |
| ONC-99055-L | OTHER | None | None |
| 935 | OTHER | None | None |