Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003061
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma NAPCL
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma
Detailed Description:
OBJECTIVES I Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma II Assess the response rate and safety of this chemotherapy regimen
OUTLINE Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging Methotrexate MTX IV is administered over 40-60 minutes on days 1 and 15 Cytarabine AraC is administered intrathecally on days 1 and 15 The second course of chemotherapy begins on day 29 or after bone marrow recovery Radiation therapy begins no later than 3 weeks after completing chemotherapy Patients are followed until death
PROJECTED ACCRUAL A maximum of 50 patients will be accrued
OUTLINE Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging Methotrexate MTX IV is administered over 40-60 minutes on days 1 and 15 Cytarabine AraC is administered intrathecally on days 1 and 15 The second course of chemotherapy begins on day 29 or after bone marrow recovery Radiation therapy begins no later than 3 weeks after completing chemotherapy Patients are followed until death
PROJECTED ACCRUAL A maximum of 50 patients will be accrued
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 |
|---|---|---|---|
| EORTC-20962 | None | None | None |