Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068250
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2003-09-10
Brief Title:
Combination Chemotherapy Monoclonal Antibody and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Study Of Pre-Irradiation Chemotherapy With Methotrexate Rituximab And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-02
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 such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Radiation therapy uses high-energy x-rays to damage cancer cells Combining methotrexate temozolomide and rituximab with radiation therapy may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma
PURPOSE This phase III trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma
Detailed Description:
OBJECTIVES
To assess the maximum tolerated dose MTD of temozolomide TMZ in combination with methotrexate MTX and rituximab RTX when administered prior to twice daily fractionated whole brain radiation therapy WBRT in patients with primary central nervous system lymphoma
To compare the two-year survival rate in patients receiving pre-irradiation chemotherapy twice daily fractionated whole brain radiation therapy and post-irradiation temozolomide to the reported two-year survival rate of Radiation Therapy Oncology Group RTOG trial 93-10 RTOG 9310 does not fall within ClinicalTrialsgov registrationreporting requirements
To compare the pre-irradiation chemotherapy tumor response rates to the reported rate from RTOG 93-10
To report progression-free survival
To assess acute and long-term neurologic toxicity and to collect quality of life data for this patient group
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
To assess the maximum tolerated dose MTD of temozolomide TMZ in combination with methotrexate MTX and rituximab RTX when administered prior to twice daily fractionated whole brain radiation therapy WBRT in patients with primary central nervous system lymphoma
To compare the two-year survival rate in patients receiving pre-irradiation chemotherapy twice daily fractionated whole brain radiation therapy and post-irradiation temozolomide to the reported two-year survival rate of Radiation Therapy Oncology Group RTOG trial 93-10 RTOG 9310 does not fall within ClinicalTrialsgov registrationreporting requirements
To compare the pre-irradiation chemotherapy tumor response rates to the reported rate from RTOG 93-10
To report progression-free survival
To assess acute and long-term neurologic toxicity and to collect quality of life data for this patient group
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000301563 | None | None | None |