Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335140
Status:
TERMINATED
Last Update Posted:
2023-07-03
First Post:
2006-06-07
Brief Title:
Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System CNS Lymphoma
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow 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 block cancer growth in different ways Some find cancer cells and kill them or carry cancer-killing substances to them Others interfere with the ability of cancer cells to grow and spread Drugs used in chemotherapy such as methotrexate leucovorin vincristine procarbazine dexamethasone and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system CNS lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate
Secondary
Determine the progression-free survival of these patients
Determine the proportion of progression-free and overall survival in these patients
Determine rituximab cerebrospinal fluid pharmacokinetics only in patients requiring intrathecal chemotherapy
OUTLINE This is a multicenter study
Patients receive rituximab IV 3 times weekly in weeks 1-4 high-dose methotrexate IV over 2 hours in weeks 1 3 5 and 9 oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1 3 5 and 9 vincristine IV in weeks 1 3 5 7 and 9 oral procarbazine hydrochloride daily on days 1-7 in weeks 1 5 and 9 oral dexamethasone daily in weeks 1-6 and cytarabine IV over 2 hours twice weekly in weeks 11 and 14
Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2 4 6 8 and 10
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Determine the complete response rate
Secondary
Determine the progression-free survival of these patients
Determine the proportion of progression-free and overall survival in these patients
Determine rituximab cerebrospinal fluid pharmacokinetics only in patients requiring intrathecal chemotherapy
OUTLINE This is a multicenter study
Patients receive rituximab IV 3 times weekly in weeks 1-4 high-dose methotrexate IV over 2 hours in weeks 1 3 5 and 9 oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1 3 5 and 9 vincristine IV in weeks 1 3 5 7 and 9 oral procarbazine hydrochloride daily on days 1-7 in weeks 1 5 and 9 oral dexamethasone daily in weeks 1-6 and cytarabine IV over 2 hours twice weekly in weeks 11 and 14
Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2 4 6 8 and 10
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| ECOG-E1F05 | OTHER | ECOG-ACRIN | None |