Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074191
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2003-12-10
Brief Title:
Methotrexate Procarbazine Lomustine 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 Procarbazine And CCNU Intraventricular Cytarabine And Methotrexate - Intra-Ocular Chemotherapy For 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-A
Brief Summary:
RATIONALE Drugs used in chemotherapy such as methotrexate procarbazine lomustine dexamethasone and cytarabine use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and efficacy of methotrexate procarbazine lomustine dexamethasone and cytarabine in patients with primary CNS lymphoma
Secondary
Determine the ability to recruit adequate numbers 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 these patients
Correlate neuropsychological outcomes with neuroimaging MRI outcomes in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Induction chemotherapy Patients receive methotrexate IV over 3 hours on days 1 10 and 20 and intraventricularly or intrathecally IT over 5 minutes on days 1 5 10 and 15 oral procarbazine on days 1-7 oral lomustine on day 1 oral dexamethasone every 6 hours on days 1-14 followed by a taper as tolerated and cytarabine intraventricularly or IT over 5 minutes on days 1 5 10 and 15 Treatment repeats every 42 days for a total of 3 courses Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam Patients with stable or responding disease proceed to maintenance therapy
Maintenance chemotherapy Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1 oral procarbazine on days 1-7 oral lomustine on day 1 oral dexamethasone every 6 hours on days 1-14 followed by a taper as tolerated and cytarabine intraventricularly or IT over 5 minutes on day 1 Treatment repeats every 42 days for a total of 5 courses
Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year
Quality of life is assessed at baseline at 6 months at the completion of treatment every 6 months for 2 years and then 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 180 patients will be accrued for this study within 3 years
Primary
Determine the toxicity and efficacy of methotrexate procarbazine lomustine dexamethasone and cytarabine in patients with primary CNS lymphoma
Secondary
Determine the ability to recruit adequate numbers 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 these patients
Correlate neuropsychological outcomes with neuroimaging MRI outcomes in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Induction chemotherapy Patients receive methotrexate IV over 3 hours on days 1 10 and 20 and intraventricularly or intrathecally IT over 5 minutes on days 1 5 10 and 15 oral procarbazine on days 1-7 oral lomustine on day 1 oral dexamethasone every 6 hours on days 1-14 followed by a taper as tolerated and cytarabine intraventricularly or IT over 5 minutes on days 1 5 10 and 15 Treatment repeats every 42 days for a total of 3 courses Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam Patients with stable or responding disease proceed to maintenance therapy
Maintenance chemotherapy Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1 oral procarbazine on days 1-7 oral lomustine on day 1 oral dexamethasone every 6 hours on days 1-14 followed by a taper as tolerated and cytarabine intraventricularly or IT over 5 minutes on day 1 Treatment repeats every 42 days for a total of 5 courses
Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year
Quality of life is assessed at baseline at 6 months at the completion of treatment every 6 months for 2 years and then 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 180 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-5729-1 | OTHER | OHSU IRB legacy number | None |
| 5729-1 | OTHER | None | None |
| ONC-99054-1 | OTHER | None | None |
| 929 | OTHER | None | None |