Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074165
Status:
TERMINATED
Last Update Posted:
2023-07-06
First Post:
2003-12-10
Brief Title:
Treating Patients With Recurrent PCNSL With CarboplatinBBBD and Adding Rituxan To The Treatment Regimen
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Trial Involving Patients With Recurrent PCNSL Treated With CarboplatinBBBD by Adding Rituxan Rituximab An Anti CD-20 Antibody To The Treatment Regimen
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as carboplatin cyclophosphamide etoposide etoposide phosphate and cytarabine use 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 tumor Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of rituximab carboplatin cyclophosphamide etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate in terms of complete response rate in patients with refractory or recurrent primary CNS lymphoma
Secondary
Determine the overall survival and 2-year progression-free survival of patients treated with this regimen
Determine the quality of life and cognitive function of patients treated with this regimen
Determine the neurotoxicity of this regimen in these patients
Determine the percentage of patients with ototoxicity over time after treatment with this regimen
Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1 On days 2 and 3 patients receive carboplatin intra-arterially over 10 minutes cyclophosphamide IV over 10 minutes and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14 Beginning 48 hours after the last dose of chemotherapy patients receive filgrastim G-CSF subcutaneously SC daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for up to 12 courses
NOTE Alternatively patients may receive a single dose of pegfilgrastim SC administered 48 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam once weekly for 1 month and then monthly for 1 year
Quality of life is assessed at baseline every 3 months during treatment within 30 days of final treatment then every 6 months for 1 year and then annually thereafter
Patients are followed monthly for 3 months every 2 months for 8 months every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 11-25 patients will be accrued for this study within 7-10 years
Primary
Determine the efficacy of rituximab carboplatin cyclophosphamide etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate in terms of complete response rate in patients with refractory or recurrent primary CNS lymphoma
Secondary
Determine the overall survival and 2-year progression-free survival of patients treated with this regimen
Determine the quality of life and cognitive function of patients treated with this regimen
Determine the neurotoxicity of this regimen in these patients
Determine the percentage of patients with ototoxicity over time after treatment with this regimen
Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients
OUTLINE This is a multicenter study
Patients receive rituximab IV on day 1 On days 2 and 3 patients receive carboplatin intra-arterially over 10 minutes cyclophosphamide IV over 10 minutes and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14 Beginning 48 hours after the last dose of chemotherapy patients receive filgrastim G-CSF subcutaneously SC daily for 7-10 days or until blood counts recover Treatment repeats every 4 weeks for up to 12 courses
NOTE Alternatively patients may receive a single dose of pegfilgrastim SC administered 48 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam once weekly for 1 month and then monthly for 1 year
Quality of life is assessed at baseline every 3 months during treatment within 30 days of final treatment then every 6 months for 1 year and then annually thereafter
Patients are followed monthly for 3 months every 2 months for 8 months every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 11-25 patients will be accrued for this study within 7-10 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 |
|---|---|---|---|
| 5R01CA137488-15 | NIH | None | None |
| ONC-02059-LX | OTHER | None | None |
| 641 | OTHER | None | None |
| 7465 | OTHER | None | None |
| OHSU-641 | OTHER | OHSU IRB | httpsreporternihgovquickSearch5R01CA137488-15 |