Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003929
Status:
WITHDRAWN
Last Update Posted:
2012-03-20
First Post:
1999-11-01
Brief Title:
Chemotherapy Filgrastim and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma PCL Using Filgrastim G-CSF
Status:
WITHDRAWN
Status Verified Date:
2012-03
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 cancer cells Combining chemotherapy with radiation therapy may kill more cancer cells Colony-stimulating factors such as filgrastim allow doctors to give higher doses of chemotherapy drugs to kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of lomustine procarbazine filgrastim and radiation therapy in treating patients who have primary central nervous system lymphoma
PURPOSE Phase II trial to study the effectiveness of lomustine procarbazine filgrastim and radiation therapy in treating patients who have primary central nervous system lymphoma
Detailed Description:
OBJECTIVES I Determine response rate response duration and survival of patients with AIDS-related or immunocompetent primary central nervous system lymphoma after treatment with oral lomustine and procarbazine filgrastim G-CSF and radiotherapy II Determine toxicity of this combined modality in these patients III Determine quality of life of these patients
OUTLINE Patients are stratified by CD4 count 50mm3 and under vs greater than 50mm3 Patients receive oral lomustine on day 1 and oral procarbazine on days 1-10 and days 22-31 Filgrastim G-CSF is administered subcutaneously daily on days 12-21 and days 33-42 until absolute neutrophil counts recover Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy Patients with a partial response stable disease or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy Quality of life is assessed prior to therapy at 3 and 6 weeks and then every 2 months following radiotherapy Patients are followed every 2 months until death
PROJECTED ACCRUAL Approximately 16 patients will be accrued for this study
OUTLINE Patients are stratified by CD4 count 50mm3 and under vs greater than 50mm3 Patients receive oral lomustine on day 1 and oral procarbazine on days 1-10 and days 22-31 Filgrastim G-CSF is administered subcutaneously daily on days 12-21 and days 33-42 until absolute neutrophil counts recover Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy Patients with a partial response stable disease or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy Quality of life is assessed prior to therapy at 3 and 6 weeks and then every 2 months following radiotherapy Patients are followed every 2 months until death
PROJECTED ACCRUAL Approximately 16 patients will be accrued for 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 |
|---|---|---|---|
| NCI-G99-1533 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-3496 | OTHER | None | None |
| CWRU-AMC-2A-93 | None | None | None |