Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416819
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2006-12-27
Brief Title:
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma A Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-08
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving rituximab together with combination chemotherapy may kill more cancer cells
PURPOSE This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma
PURPOSE This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the rate of toxicity in terms of percentage of patients with grade 4 neurotoxicity in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate leucovorin calcium rituximab and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate
Secondary
Determine the efficacy of this regimen in terms of the 4-month and 12-month complete and best response rate in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the percentage of patients experiencing toxicity or neurotoxicity due to this regimen
Determine the treatment-related mortality rate in patients treated with this regimen
Document the neurocognitive changes in these patients using the Mini-Mental Status Examination during the first year of treatment with this regimen
OUTLINE This is a pilot multicenter study
Induction therapy Patients receive high-dose methotrexate IV over 4 hours on days 115 29 43 57 71 and 99 leucovorin calcium IV every 6 hours on days 2-4 16-18 30-32 44-46 58-60 72-74 and 100-102 oral temozolomide on days 7-11 35-39 63-67 91-95 and 119-123 and rituximab IV on days 3 17 31 45 59 and 74 Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response proceed to consolidation therapy
Consolidation therapy I Beginning 3-4 weeks after completing induction therapy patients receive high-dose methotrexate IV over 4 hours on day 1 leucovorin calcium IV every 6 hours on days 2-4 and oral temozolomide on days 7-11
Consolidation therapy II Beginning 3-5 weeks after completing consolidation therapy I patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV continuously on days 1-4 and filgrastim G-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
After completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued to this study
Primary
Determine the rate of toxicity in terms of percentage of patients with grade 4 neurotoxicity in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate leucovorin calcium rituximab and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate
Secondary
Determine the efficacy of this regimen in terms of the 4-month and 12-month complete and best response rate in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the percentage of patients experiencing toxicity or neurotoxicity due to this regimen
Determine the treatment-related mortality rate in patients treated with this regimen
Document the neurocognitive changes in these patients using the Mini-Mental Status Examination during the first year of treatment with this regimen
OUTLINE This is a pilot multicenter study
Induction therapy Patients receive high-dose methotrexate IV over 4 hours on days 115 29 43 57 71 and 99 leucovorin calcium IV every 6 hours on days 2-4 16-18 30-32 44-46 58-60 72-74 and 100-102 oral temozolomide on days 7-11 35-39 63-67 91-95 and 119-123 and rituximab IV on days 3 17 31 45 59 and 74 Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response proceed to consolidation therapy
Consolidation therapy I Beginning 3-4 weeks after completing induction therapy patients receive high-dose methotrexate IV over 4 hours on day 1 leucovorin calcium IV every 6 hours on days 2-4 and oral temozolomide on days 7-11
Consolidation therapy II Beginning 3-5 weeks after completing consolidation therapy I patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV continuously on days 1-4 and filgrastim G-CSF subcutaneously beginning on day 14 and continuing until blood counts recover
After completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued to this study
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 |
|---|---|---|---|
| UCSF-H9414-23160-02A | None | None | None |
| UCSF-03301 | None | None | None |